BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS

    MDR report key: 5404035 · Received February 2, 2016

    Report

    Report Number
    5404035
    Event Type
    Malfunction
    Date Received
    February 2, 2016
    Date of Event
    November 24, 2015
    Report Date
    November 24, 2015
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE METAL TIP DETACHED FROM THE WAND. IT WAS SEEN AT BACK OF KNEE ON A SCOPE. THERE WAS METAL AND PLASTIC IN THE JOINT SPACE. NOT ALL PLASTIC WAS RECOVERED BY THE SURGEON. SOME PARTS WERE RECOVERED. ADDED 30 MINUTES TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62542 SERFAS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY 14053AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR