BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS UNIDIRECTIONAL FOOTSWITCH

    MDR report key: 4103091 · Received September 19, 2014

    Report

    Report Number
    0001811755-2014-03303
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS CONFIRMED THROUGH FUNCTIONAL EVALUATION THAT THE HANDPIECE CONTINUED TO RUN AFTER THE FOOT PEDAL WAS RELEASED. UPON DISASSEMBLY, THE MAGNET WAS FOUND TO BE LOOSE DUE TO A LACK OF LOCTITE, WHICH MAY CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TESTING AT THE MANUFACTURER FACILITY, THE TPS UNIDIRECTIONAL FOOTSWITCH WAS CAUSING THE HANDPIECE TO RUN WITHOUT USER ACTIVATION AFTER THE TRIGGER WAS RELEASED. NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT. AS THIS EVENT OCCURRED DURING TESTING, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582650 TPS UNIDIRECTIONAL FOOTSWITCH UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1