Hem-o-Lok Clip Is Safe in Minimally Invasive General Surgery: A Single Center Experience and Review of Data From Food and Drug Administration
BackgroundThere 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.
ObjectivesIn 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.Patients and
MethodsWe 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.
ResultsOver 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.
ConclusionsHem-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.
Journal of Minimally Invasive Surgical Sciences, Volume:1 Issue:2, 2012
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