inforMED
MalfunctionGEI

GIMMI

Received Sep 8, 2021 · Event occurred Sep 2, 2021

Report MW5103785 · MDR key 12446384

Device

Generic name

Electrosurgical, Cutting & Coagulation & Accessories

Manufacturer

Gimmi Gmbh

Catalog number

T.8080.03

Product problems

  • Thermal Decomposition of Device
  • Overheating of Device

Patient

Not reported

  • Superficial (First Degree) Burn
  • Superficial (First Degree) Burn

Narrative

Description of Event or Problem

THE TROCAR IS A METAL TROCAR AND A L HOOK WAS INSERTED THROUGH IT AND USED AS AN ELECTROCAUTERY. APPARENTLY, THE INSULATION COATING ON THE L HOOK BECAME OVERHEATED AND WAS BURNED. NO FLAMES WERE SEEN, BUT YOU CAN SEE CHARRING 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 CHARRING 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 1 CM) BURN ON THE PATIENT'S SKIN AT THE TROCAR INSERTION SITE. THE PROCEDURE WAS A LAP CHOLECYSTECTOMY. FDA SAFETY REPORT ID # (B)(4).