BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY PROBE

    MDR report key: 2792397 · Received September 28, 2012

    Report

    Report Number
    2792397
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    May 11, 2012
    Report Date
    September 28, 2012
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE USING THE ARTHROSCOPIC WAND THE HEAD BROKE OFF IN THE JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY PROBE ELECTROSURGICAL, CUTTING, COAGULATION GEI STRYKER ENDOSCOPY 279-351-300 12107AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR