BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTION

    MDR report key: 2841561 · Received November 21, 2012

    Report

    Report Number
    1045254-2012-00684
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ERL
    PMA / PMN Number
    K081277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE COMPLAINT WAS CONFIRMED. THE PEDAL'S SPRINGS WERE BAD. THE SPRINGS WERE REPLACED AND THE DEVICE THEN PERFORMED TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC SERVICE AND REPAIR THAT A FOOT PEDAL WOULD NOT STOP RUNNING WHEN PLUGGED IN. THIS HAPPENED DURING PRE-OP. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCH 1895420 XPS MULTIFUNCTION DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL XOMED MFG JACKSONVILLE 1895420 57736200

    Patients

    Seq Age Sex Outcome Treatment
    1