BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR HANDLE WITH L-HOOK

    MDR report key: 734282 · Received June 5, 2006

    Report

    Report Number
    734282
    Event Type
    Malfunction
    Date Received
    June 5, 2006
    Date of Event
    April 20, 2006
    Report Date
    June 5, 2006
    Manufacturer
    SRI SURGICAL
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC CHOLECYSTECTOMY THE MD WAS CAUTERIZING THE LIVER BED AND NOTICED THAT THE CAUTERY HOOK BEING USED WAS NOT INSULATED COMPLETELY TO THE TIP. INSTRUMENT WAS TAKEN OUT OF USE. NO HARM TO PATIENT. RECOGNIZED AS A POTENTIAL PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR HANDLE WITH L-HOOK HANDLE, CAUTERY GEI SRI SURGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR