BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIPOLAR FORCEPS 8", 0.5MM STRAIGHT TIPS

    MDR report key: 12301279 · Received August 9, 2021

    Report

    Report Number
    MW5103105
    Event Type
    Malfunction
    Date Received
    August 9, 2021
    Date of Event
    August 5, 2021
    Report Date
    August 5, 2021
    Manufacturer
    KATALYST SURGICAL, LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF THE BIPOLAR BENT AND BROKE OFF WHILE IN USE DURING BRAIN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191369 DISPOSABLE BIPOLAR FORCEPS 8", 0.5MM STRAIGHT TIPS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI KATALYST SURGICAL, LLC. M21550

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR