BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSFIRE FOOTSWITCH

    MDR report key: 2251076 · Received August 9, 2011

    Report

    Report Number
    2936485-2011-00564
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WOULD NOT WORK WHEN USING THE DEFAULT RF/SHAVER CONTROLS. IT WAS FURTHER REPORTED THAT THE HAND PIECE KEPT ON RUNNING WHEN THE FOOTSWITCH ON THE UNIT WAS PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSSFIRE FOOTSWITCH FOOTSWITCH GEI STRYKER ENDOSCOPY SAN JOSE 11E056604

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK