BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPR 90 DEGREE HOOK ELECTRODE

    MDR report key: 1584199 · Received January 15, 2010

    Report

    Report Number
    MW5014405
    Event Type
    Injury
    Date Received
    January 15, 2010
    Date of Event
    January 13, 2010
    Report Date
    January 15, 2010
    Manufacturer
    DEPUY MITEK, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SURGEON WAS USING CAUTERY HOOK IN SHOULDER CAPSULE WHEN IT SNAPPED OFF. SURGEON BROUGHT IN CARM AND SEARCHED FOR 4 HOURS TRYING TO REMOVE. SURGEON WAS UNABLE TO RETRIEVE SMALL METAL HOOK FROM SHOULDER CAPSULE. PATIENT WILL NEED TO HAVE SECOND SURGERY TO REMOVE PIECE. DATES OF USE: (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: LEFT SHOULDER ARTHROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPR 90 DEGREE HOOK ELECTRODE VAPR 90 DEGREE HOOK ELECTRODE GEI DEPUY MITEK, INC. VAPR 90 DEGREE M0806007

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| S