BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPIC ELECTRODE PTFE COATED WIRE L HOOK

    MDR report key: 5356846 · Received January 11, 2016

    Report

    Report Number
    5356846
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    January 4, 2016
    Report Date
    January 5, 2016
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE SURGEON WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY WITH A 35CM LAPAROSCOPIC "L" HOOK, THE HOOK COULD NOT BE REMOVED FROM THE 5MM TROCAR- IT BENT. QUESTIONABLE HEAT TRANSFER VIA BENT HOOK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16910 LAPAROSCOPIC ELECTRODE PTFE COATED WIRE L HOOK ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI PROGRESSIVE MEDICAL, INC. 1505031

    Patients

    Seq Age Sex Outcome Treatment
    1