BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERFAS ENERGY 90 S

    MDR report key: 2250639 · Received September 1, 2011

    Report

    Report Number
    2250639
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 24, 2011
    Report Date
    September 1, 2011
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FLAKING NOTED WITH TWO STRYKER SERFAS ENERGY 90-S 3.5 MM WANDS DURING USE: WAND 1) THE BLACK PLASTIC FLAKED OFF THE SHAFT. WAND 2) WHITE TIP CHIPPED OFF. ALL WANDS WITH LOT NUMBER 11195AE2 WERE REMOVED FROM THE SHELVES, AND NO FURTHER ONES WILL BE ORDERED WITH THIS LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERFAS ENERGY 90 S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY 90 S 11195AE2
    2 SERFAS ENERGY 90 S ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI STRYKER ENDOSCOPY 90 S 11195AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR