BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL

    MDR report key: 2816919 · Received November 2, 2012

    Report

    Report Number
    1045254-2012-00664
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    ERL
    PMA / PMN Number
    K041523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). ANALYSIS OF THE COMPLAINT DEVICE BY MEDTRONIC CONFIRMED THAT THERE WAS AN ISSUE WITH THE SPRING. THE SPRING WAS MISSING. MEDTRONIC REPLACED THE SPRING AND TESTED THE UNIT. THE PEDAL NO LONGER STICKS. THE UNIT MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPRING ON THE BOTTOM OF A FOOTSWITCH POPPED OUT OF PLACE. DUE TO THIS, THE FOOT PEDAL WOULD STICK DOWN AND RUN ON ITS OWN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC 1895420 71014800

    Patients

    Seq Age Sex Outcome Treatment
    1