Prof. Dr. R. K. Mishra. MRCS,M.MAS (U.K).
Download full video of broken clip applicator during laparoscopic cholecystectomy
During live surgery breakage of instruments is rare. However, if this does occur sometime if the instrument is not from reliable company, locating and retrieving the broken part of the instrument could be cumbersome and time taking. Moreover, if accidentally it is missed it can do so may carry serious medico legal implications. We report a patient in whom the tip of a Clip applicator broke during laparoscopic surgery. This was located by surgeon intra operative and retrieved using grasper through the cannulla. There are many probable factors responsible for breakage of laparoscopic instrument within our patient and looks at the previously reported cases of the rare complication of breakage of instruments during laparoscopic surgery.
It is essential to keep in mind that just about all laparoscopic instruments are introduced into the abdominal cavity through ports and therefore their tips do not talk with any amount of resistance and the tip of the instrument should not be closed too tightly. In our patient as you can see on above video while clipping the cystic duct the clip applicator was broken. During laparoscopic procedures, thin instruments with delicate, sharp tips are introduced through the cannulla to control intra abdominal structures, and breakage of the tip of those instruments is really a well-recognised complication. To guard against this eventuality in laparoscopic surgery, it is important to make sure that delicate instruments like clip applicator scissors or suture passer don't have soldered parts in the tip which will make them prone to breakage during surgery. Furthermore, if during manufacture or repair of the laparoscopic instrument the inexpensive lead-based or silver solder can be used, it weakens the instrument because it is applied at high temperatures. Following the utilization of such silver solder, the laparoscopic instrument is much more prone to break during live surgery. Repeated autoclaving of reusable laparoscopic instruments may weaken them making them vulnerable to breakage. Routine and thorough checking from the laparoscopic instruments by those accountable for their maintenance can help avoid intra operative breakage.
With the literature review we found that, many surgeons has reported the breaking of different instruments during laparoscopic surgery. Salameh reported two cases of breakage from the tip of Gore suture passer (W. L. Gore, & Associates, Newark, DE) during laparoscopic repair of ventral hernia. This author points out that the common mechanism of breakage of suture passer is its withdrawal inside a partially open position so that the tip catches on the fascia and breaks. Also, changing the direction from the suture passer midway through its introduction is likely to create opposing shear forces around the tip leading to its breakage. Thus, these two points have to be guarded against when utilizing a suture passer to prevent breakage of its tip.
Most of the time if an instrument breaks during laparoscopic surgery and the broken part lies in the operative field, it can be retrieved immediately. For example in his paper, Lynch et al reported the breakage and recovery of a 2-mm segment of needle from an Autosuture Endostitch device (U.S. Surgical) throughout a laparoscopic Burch procedure that was retrieved uneventfully. Often, however, the breakage becomes apparent after some time or the broken part may migrates within the abdominal cavity, making its retrieval very difficult by laparoscopy. Use of intra operative fluoroscopy is very useful if the tip of the instrument is actually missed and it is an option to locate and remove the broken instrument part. Kandioler-Eckersberger et al describe the use of a novel approach to identify the tip of a reusable laparoscopic grasper that was lost between looped bowel in two cases. After initial unsuccessful attempts at retrieval by patient positioning, fluoroscopic localization, endoscopic visualization etc, they have sometime used a magnetic probe to retrieve the broken parts of laparoscopic instrument. The probe contains a 6-cm magnetic tip attached to a 40-cm semi flexible Teflon rod. The probe was passed through among the ports and was placed in the vicinity from the lost part under fluoroscopic guidance; the lost metallic piece was drawn to the magnet. It was retrieved along with a laparotomy was avoided.
For the surgeon action that should be taken after a bad event involving breakage of the medical device varies from hospital to hospital. It is important to document the event at the same time records and report it towards the hospital authority to avoid medico legal issue. In the Western countries this may also have to be reported towards the relevant state authority in prescribed forms. Like in USA FDA has to be informed if any instrument break during surgery.
In accordance with section 520(g) and the regulations of FDA, clinical studies of medical devices must comply with FDA’s human subject protection requirements (informed consent and additional safeguards for children in research) (21 CFR Part 50),Discussion using the patient of the complication and the remedial measures taken helps place the event in perspective and may lessen the probability of a legal action. If appropriate, the information ought to be passed on to the insurer indemnifying choices as well as their opinion sought in an initial phase.
In conclusion, it should be kept in mind that breakage of instruments is rare during laparoscopic surgery but may occur with the use of thin, sharp instruments. The OT staff and surgeon should make a periodical system of checking all the instrument. Periodic inspection of delicate laparoscopic instruments as well as their careful maintenance and use should help guard against such mishaps during laparoscopic surgery.
