Hem-o-Lok clip is safe in minimally invasive general surgery: a single center experience and review of data from food and drug administration

ABSTRACT

There are several methods for the ligation of structures during minimally invasive operations. The hem-o-lok clip is a nonabsorbable polymer clip with a lock engagement feature. There are few reports about its use in minimally invasive general surgical procedures. In this report, we describe our experience with the hem-o-lok clip during basic, minimally invasive, general surgery procedures and the adverse events during application of the hem-o-lok. We retrospectively reviewed all laparoscopic appendectomies [LAs], cholecystectomies [LCs], and splenectomies [LSs], performed by 6 general surgeons at a university-affiliated hospital over 4 years. Clip failure was defined as intraoperative or postoperative bleeding due to clip malfunction that necessitated placement of another clip, conversion to an open procedure, or postoperative re-exploration. Leakage from the cystic duct and appendiceal stump was also considered clip failure. A search of the US Food and Drug Administration Manufacturer and User Facility Device Experience [MAUDE] database using the appropriate keywords was performed on July 7, 2011. This online resource contains reports of adverse events involving medical devices. Over a 4-year period, 856 laparoscopic operations, comprising 770 LC, 55 LS, and 31 LA, were performed. We did not observe any incidence of clip failure. There were 22 reports of hem-o-lok clip failure in the MAUDA database. Eighty-two percent [n=18] of clip failures were reported during laparoscopic nephrectomy. There was no report of failure after LA. There were 2 reported clip failures after LC [with bile leakage] and 1 after LS [tearing of splenic vessels with intraoperative bleeding]. There was also a report of migration of the hem-o-lok clip into the common bile duct, which occurred 4 years after a complicated LC. Hem-o-lok clips that are properly applied during basic laparoscopic procedures are a secure option for the ligation of the structures. Surgeons must be educated regarding the proper application technique