BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALIS NERVE HOOK

    MDR report key: 6056863 · Received October 26, 2016

    Report

    Report Number
    6056863
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    May 31, 2016
    Report Date
    September 20, 2016
    Manufacturer
    SYMMETRY SURGICAL, INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF NERVE HOOK BROKE OFF DURING SURGERY. TIP OF NERVE HOOK WAS FOUND IN THE DRAPES PRIOR TO THE END OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707402 MALIS NERVE HOOK HOOK, SURGICAL, GENERAL & PLASTIC SURGERY GDG SYMMETRY SURGICAL, INC. GERMANY 096

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR