GIMMI GMBH

Description of Event or Problem

ACCORDING TO USER FACILITY REPORT NO. MW5103785 THE EVENT WAS DESCRIBES AS FOLLOWS:THE TROCAR IS A METAL TROCAR, AND A L-HOOK WAS INSERTED THROUGH IT AND USED AS AN ELECTROCAUTERY. THE INSULATION COATING ON THE L-HOOK BECAME OVERHEATED AND WAS BURNED. NO FLAMES WERE SEEN, BUT YOU CAN SEE CHARGING ON THE INSIDE OF THE TROCAR MOUTH AND YOU CAN SEE WHERE THE INSULATION WAS CHARRED AND PEELED ON THE L-HOOK. THE OR TEAM NOTICED LITTLE PIECES OF CHARGING ON THE DEVICE ALONG WITH CHARRED FLECKS. THE PHYSICIAN PROMPTLY REMOVED THE DEVICE WHEN HE NOTICED THIS AND IRRIGATED. WHEN HE PULLED THE METAL TROCAR OUT, HE NOTICED A SMALL (ABOUT 1CM) BURN ON THE PATIENT'S SKIN AT THE TROCAR INSERTION SITE. THE PROCEDURE WAS A LAP CHOLECYSTECTOMY., FDA SAFETY REPORT ID # (B)(4); MW5103785.