BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALLEY LAB - FORCE FX C

    MDR report key: 288315 · Received August 3, 2000

    Report

    Report Number
    288315
    Event Type
    Injury
    Date Received
    August 3, 2000
    Date of Event
    June 29, 2000
    Report Date
    July 13, 2000
    Manufacturer
    VALLEY LAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY PT SUFFERED BURN TO LEFT CHEEK FROM BOVIE INSTRUMENT TIP. AFTER THE GALLBLADDER WAS REMOVED THE SKIN AREA WAS BEING CAUTERIZED ALONG THE SUPRAUMBILICAL INCISION. SMOKE WAS NOTED COMING FROM THE TOP DRAPE. THE BOVIE INSTRUMENT TIP HAD GONE THROUGH THE DRAPE AND WAS LAYING AGAINST THE LEFT SIDE OF THE PT'S FACE, INCURRING A SMALL BURN. LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WAS COMPLETED. THE LEFT CHEEK BURN WAS 1 CM WIDE BY 2 CM IN LENGTH. A FULL THICKNESS BURN WITH A CHARRED CENTRAL AREA AND SOME NECROSIS WAS NOTED AROUND A 2 MM PERIMETER. THE BURNED AREA WAS EXCISED AND REPAIRED BY A PLASTIC SURGEON FOLLOWING CONCLUSION OF LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. EQUIPMENT WAS CHECKED BY BIOMEDICAL STAFF AND FOUND TO BE WITHOUT DEFECT. IT WAS NOTED THAT TWO BOVIE TIPS WERE CONNECTED IN ONE PORT SO ONE FOOT PEDAL OPERATED BOTH BOVIES. UPON FURTHER ANALYSIS THE USER'S GUIDE NOTED THAT INSTRUMENT RECEPTACLES ON THIS TYPE OF GENERATOR ARE DESIGNED TO ACCEPT ONLY ONE INSTRUMENT INTO A GIVEN RECEPTACLE. TWO ISSUES WERE IDENTIFIED DURING THE HOSP INVESTIGATION: 1. SURGERY STAFF INDICATE DURING TRAINING BY VALLEY LAB SALES REP THAT THIS IMPORTANT SAFETY WARNING, I.E., ONLY ONE INSTRUMENT IN ONE RECEPTACLE, WAS NEVER BROUGHT OUT. STAFF WERE NEVER MADE AWARE OF WARNING. 2. WHY DOES EQUIPMENT ALLOW MORE THAN ONE INSTRUMENT TO BE USED IN ONE RECEPTACLE IF THIS IS A SAFETY ISSUE? ACTIONS TAKEN BY HOSP: 1. WARNING LABELS PUT ON GENERATOR FOR ONLY ONE INSTRUMENT TO BE USED IN ONE RECEPTACLE. 2. EDUCATION PROVIDED TO SURGERY STAFF REGARDING USE OF ONE INSTRUMENT IN ONE RECEPTACLE IN GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VALLEY LAB - FORCE FX C ELECTROSURGICAL GENERATOR & BOVIE TIP GEI VALLEY LAB FORCE FX C *

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R