BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSE FOOTSWITCH

    MDR report key: 2971639 · Received February 21, 2013

    Report

    Report Number
    0001811755-2013-00334
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    ERL
    PMA / PMN Number
    K040300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON VISUAL INSPECTION OF THE DEVICE, A CUT IN THE ELECTRIC CABLE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD BARE EXPOSED COPPER WIRES. NO ADDITIONAL INFORMATION ABOUT THE EVENT IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76577 NSE FOOTSWITCH DRILL, SURGICAL, ENT ERL STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1