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Surg Endosc (2010) 24:462–465

DOI 10.1007/s00464-009-0601-5

Insulation failure in laparoscopic instruments


Paul N. Montero Æ Thomas N. Robinson Æ
John S. Weaver Æ Greg V. Stiegmann

Received: 20 February 2009 / Accepted: 16 June 2009 / Published online: 2 July 2009
Ó Springer Science+Business Media, LLC 2009

Abstract that routinely checked for insulation failure (19%; 25/130)


Background Electrosurgery is used in virtually every and hospitals that do not routinely check for insulation
laparoscopic operation. In the early days of laparoscopic failures (33%; 7/21; p = 0.16). Insulation failure was most
surgery, capacitive coupling, associated with hybrid tro- common in the distal third of the instruments (54%; 25/46)
cars, was thought to be the major cause of laparoscopic compared to the middle or proximal third of the instruments
electrosurgery injuries. Modern laparoscopy has reduced (*p \ 0.05).
capacitive coupling, and now insulation failure is thought Conclusion One in five reusable laparoscopic instruments
to be the main cause of electrosurgical complications. The has insulation failure; a finding that is not altered by
aim of this study was (1) to determine the incidence of whether the hospital routinely checks for insulation defects.
insulation failures, (2) to compare the incidence of insu- Disposable instruments have a lower incidence of insula-
lation failure in reusable and disposable instruments, and tion failure. The distal third of laparoscopic instruments is
(3) to determine the location of insulation failures. the most common site of insulation failure.
Methods At four major urban hospitals, reusable laparo-
scopic instruments were checked for insulation failure Keywords Radiofrequency  Monopolar electrosurgery 
using a high-voltage porosity detector. Disposable L-hooks Laparoscopic  Insulation failure
were collected following laparoscopic cholecystectomy
and similarly evaluated for insulation failure. Instruments
were determined to have insulation failure if 2.5 kV cros-
sed the instrument’s insulation to create a closed loop Monopolar radiofrequency electrosurgery is used in virtu-
circuit. Statistical analysis was performed using Fisher’s ally every laparoscopic operation. Injury from inadvertent
exact or v2 analysis (*denotes significance set at p \ 0.05). energy transfer has a reported incidence of 1-5 recognized
Results Two hundred twenty-six laparoscopic instruments injuries per 1,000 cases [1, 2]. Many such injuries create
were tested (165 reusable). Insulation failure occurred more catastrophic complications [3] and result in medicolegal
often in reusable (19%; 31/165) than in disposable instru- actions [4].
ments (3%; 2/61; *p \ 0.01). When reusable sets were Four types of laparoscopic electrosurgery injury patterns
evaluated, 71% (12/17) were found to have at least one exist: insulation failure, capacitive coupling, direct cou-
instrument with insulation failure. Insulation failure inci- pling, and direct application [5, 6]. In the early days of
dence in reusable instruments was similar between hospitals laparoscopic surgery, use of hybrid (a combination of
plastic and metal) trocars lent to the occurrence of capac-
itive coupling, which was thought to be the major cause of
P. N. Montero  T. N. Robinson (&)  J. S. Weaver  laparoscopic electrosurgery injuries [7, 8]. Modern elec-
G. V. Stiegmann trosurgery generators [9] and guidelines to avoid the use of
Department of Surgery, University of Colorado Denver School
hybrid trocars [10] have reduced capacitive coupling;
of Medicine, 12631 East 17th Ave., MS C313, P.O. Box 6511,
Aurora, CO 80045, USA insulation failure is now thought to be a main cause of
e-mail: thomas.robinson@uchsc.edu laparoscopic electrosurgery injuries.

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The purpose of this study was to examine laparoscopic instruments (3%; 2/61; *p \ 0.01). When reusable sets
insulation defects. The specific aims of this study were (1) were evaluated, 71% (12/17) were found to have at least
to determine the incidence of insulation failures, (2) to one instrument with insulation failure. Insulation failure
compare the incidence of insulation failure in reusable and incidence in reusable instruments was similar between
disposable instruments, and (3) to determine the location of hospitals that routinely checked for insulation failure (19%;
insulation failures. 25/130) and hospitals that did not routinely check for
insulation failure (33%; 7/21; p = 0.16).
In the reusable instruments, 46 insulation defects were
Methods identified in 32 instruments. More than one insulation
failure was found in eight (25%) reusable instruments.
Regulatory exemption due to designation as nonhuman Three reusable instruments had two insulation defects, four
research was obtained from the Colorado Multi-Institu- reusable instruments had three such leaks, and one reusable
tional Review Board (COMIRB #08-1377). Laparoscopic instrument had four sites of failure.
instrument insulation was tested using the Micromed PD- The location of the insulation failure was most common
8 K (Blackstone, MA) porosity detector. Using a 2.5-kV in the distal third of the instruments (54%; 25/46) com-
interrogation current, an insulation failure was defined as pared with the middle or proximal third of the instruments
present when current crossed the insulation and created a (*p \ 0.05) (Fig. 1).
closed loop circuit, signaling an alarm and creating a visible
arc.
Reusable instruments (n = 165) from four major urban Discussion
hospitals were tested. Two of the four hospitals routinely
tested their laparoscopic instruments for insulation failure. One in five reusable laparoscopic instruments has insula-
All reusable instruments underwent mechanized steriliza- tion failure, a finding that is not altered if the hospital
tion after each use. Disposable L-hook active electrodes routinely checks for insulation defects. One in four reus-
(n = 61) were tested after a single-use following laparo- able laparoscopic instruments had more than one defect in
scopic cholecystectomy. Disposable L-hooks were obtained their insulation. Disposable instruments have a lower
from Covidien (Boulder, CO), Conmed (Centennial, CO), incidence of insulation failure compared with reusable
and Megadyne (Draper, UT). All laparoscopic instruments instruments. The distal third of laparoscopic instruments is
evaluated had a 30-cm length of insulation. Location of an the most common site of insulation failure.
insulation defect was defined from 0 cm (adjacent to Monopolar radiofrequency electrosurgery is a univer-
working tip) to 30 cm (adjacent to handle). All operations sally used tool for laparoscopic procedures. This technology
were performed with disposable (all plastic) trocars was initially thought to be contraindicated in laparoscopic
(Table 1). applications because of fears of high complication rates
Statistical analysis was performed using Fisher’s exact or [11]. Contributing factors to laparoscopic electrosurgery
v2 analysis for dichotomous variables and Student’s t test injuries include a limited field of vision and four known
for continuous variables. Significance was set at p \ 0.05. mechanisms for inadvertent energy transfer: insulation
failure, capacitive coupling, direct coupling, and direct
application [5, 6].
Results Insulation failure of a laparoscopic instrument is defined
as a break or defect in the insulation that coats the instru-
In August 2008, 226 instruments (165 reusable and 61 ment. Insulation failure is caused by excessive use of reus-
disposable) were tested; we found that 33 (15%) instru- able instruments, particularly with repetitive passage
ments had insulation failure(s). Insulation failure occurred through trocars and frequent mechanized sterilization pro-
more often in reusable (19%; 31/165) than in disposable cessing [12]. High voltages carried with certain electrosur-
gical power modes (e.g., coagulation mode) can also
Table 1 Insulation failures in laparoscopic instruments contribute to defects by weakening insulation over time [13].
Insulation material applied to laparoscopic instruments is
Insulation defect
typically heat shrink material made from a variety of com-
Absent Present pounds including polyvinylidene fluoride, polyethylene, and
polyvinyl chloride. Because both reusable and disposable
Reusable instruments 81% (134/165) 19% (31/165)
instruments in this study were manufactured by several
Disposable instruments 97% (59/61) 3% (2/61)
different companies, the instruments studied had more than
Reusable instrument sets 29% (5/17) 71% (12/17)
one type of insulation material. Most laparoscopic

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Fig. 1 Location of insulation defect and clinical significance. Distri- relevant insulation defects, a monitor (i.e., the surgeon’s view) and a
bution of the insulation defects along the shaft of a 30-cm laparoscopic cannula are drawn. Six insulation defects (18%) occurred outside the
instrument is depicted. A laparoscopic instrument is drawn below the view of the monitor and beyond the protection of the cannula, a
graph with the length of the shaft of the instrument exactly overlying location known to create catastrophic unrecognized injuries [6]
the 30 cm of the graph’s x axis. To highlight the most clinically

equipment has insulation material that is at least 0.008 in. as the instrument is withdrawn from the trocar. In Fig. 1, a
thick. In this study, many insulation defects were visible monitor and cannula are superimposed on a graphic dis-
prior to instrument testing. A large number of defects, tribution of insulation defects, highlighting the incidence of
however, were not apparent until our porosity detector was the most clinically relevant insulation defects.
passed over the shaft. Such defects in instrument insulation The main limitations of this study are fourfold. First, the
can deliver most or all of the current to unintended tissues clinical significance of these insulation defects is difficult
[9]. This study does not address if the surgeon can detect to extrapolate without in vivo histological testing of vul-
insulation defects at the start of the surgical procedure. nerable tissue (i.e., bowel) exposed to the insulation defects
However, careful inspection of instruments with a porosity at clinically relevant electrosurgery generator power set-
detector clearly detects insulation defects present in both tings. Indeed, to our knowledge, no clinically identified
reusable and disposable instruments. complications resulted from use of the defective instru-
The first important finding of this study was the high ments we discussed. However, our data collection sug-
incidence of insulation failure in reusable laparoscopic gested that the insulation defects appeared relevant since
instruments. Interestingly, despite testing for such defects sparks frequently arced between the interrogation current
in some hospitals, we found similar rates of insulation probe and the exposed active electrode. Second, the rele-
failure for hospitals that check for insulation failure and for vance of an insulation defect was counted equally in all
those that do not. These findings should alert the laparo- instruments. This accounting is suboptimal since insulation
scopic surgeon that every laparoscopic instrument set defects in instruments commonly used as active electrodes
likely has one or more reusable instruments with an insu- (i.e., L-hooks and spatulas) carry a much greater clinical
lation defect. From a system perspective, hospitals should significance in comparison with assistant and dissecting
consider instituting methodical insulation failure detection instruments that are not commonly used as the active
programs to survey their laparoscopic equipment. electrode. Third, laparoscopic instruments were tested with
The second important finding of this study was that 18% only one voltage setting. Completion of the closed loop
of insulation defects are located in the section of the circuit of the porosity detector is dependent on the thick-
instrument most likely to create a catastrophic electrosur- ness of the defect and the voltage used for testing. We
gical injury. Originally described as ‘‘Zone 2’’ by Voyles chose 2.5 kV as this mimics coagulation mode at 30 W, a
and Tucker [6], the location along the instrument, which is commonly used setting. Other interrogation current settings
outside the view of the monitor but distal to the protective would signal alarms at different depths of insulation defect.
cannula, carries the highest risk for creating an injury that Finally, the defects were not quantified in any manner.
even the most attentive surgeon is unable to detect. This Although visible arcs of up to 5 mm were seen during
clinically relevant section of the instrument increases as the testing, we did not measure or record any data regarding
instrument is further inserted into the trocar and decreases size of the arc. We did not quantify the current across the

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insulation defect in relation to size or whether the active 3. Feder BJ (2006) Surgical device poses a rare but serious peril.
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Acknowledgments The authors gratefully acknowledge the tech- 202:520–530
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