BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR WIRELESS FOOTSWITCH

    MDR report key: 2442654 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00009
    Event Type
    Malfunction
    Date Received
    January 20, 2012
    Report Date
    October 14, 2010
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MANUFACTURER. THE SERIAL NUMBER OF THE PULSAR FOOTSWITCH IS UNKNOWN; THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. SERIAL/LOT NUMBERS WERE NOT PROVIDED FOR EITHER THE TNA HANDPIECE, GENERATOR OR FOOTSWITCH SO THE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE WHEN THE PHYSICIAN RELEASED THE FOOT PEDAL THE PLASMABLADE WAS STILL ACTIVE. THE SALES REP UNPLUGGED THE HAND PIECE FROM THE GENERATOR TO DEACTIVATE IT. ONCE PLUGGED BACK IN, IT WORKED FINE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSAR WIRELESS FOOTSWITCH GEI PEAK SURGICAL, INC. PULSAR FOOTSWITCH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NOT AVAILABLE