BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER SERFAS

    MDR report key: 818933 · Received February 8, 2007

    Report

    Report Number
    818933
    Event Type
    Other
    Date Received
    February 8, 2007
    Date of Event
    February 2, 2007
    Report Date
    February 2, 2007
    Manufacturer
    STRYKER ENDOSCOPY
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SERFAS ENERGY UNIT BEING USED INTRA-OPERATIVELY ON SHOULDER ARTHROSCOPY. (WAND 90-S 3.5 MM). AFTER USE ON PATIENT THE UNIT ALARMED WHILE NOT IN USE- "E8 ERROR CODE." WAND CHANGED AND UNIT RESET. AT END OF CASE, PATIENT NOTED TO HAVE "REDDENED AREA, WEEPING AREA LESS THAN 1 CM IN SIZE" AT PORTAL SITE OF SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER SERFAS SERFAS ENERGY RF GENERATOR GEI STRYKER ENDOSCOPY 279-000-000 07004AE2

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other