BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIMMI GMBH

    MDR report key: 12681875 · Received October 22, 2021

    Report

    Report Number
    9612074-2021-00001
    Event Type
    Malfunction
    Date Received
    October 22, 2021
    Date of Event
    September 2, 2021
    Report Date
    October 22, 2021
    Manufacturer
    GIMMI GMBH
    Product Code
    GEI
    UDI-DI
    04049047640868
    PMA / PMN Number
    K012660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1580379 GIMMI GMBH ALPHADUR MONOPOLAR LAP L-HOOK GEI GIMMI GMBH T.0120.62 44204210 04049047640868

    Patients

    Seq Age Sex Outcome Treatment
    1 Other