BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 3970617 · Received July 31, 2014

    Report

    Report Number
    0001811755-2014-02734
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    EIA
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT WAS NOT CONFIRMED AND NO OTHER FAILURES WERE FOUND DURING THE DEVICE EVALUATION. THE DEVICE WAS DISCARDED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE CONDUCTED BY A MANUFACTURER FIELD SERVICE TECHNICIAN AT THE USER FACILITY, THE TPS HANDPIECE CORD WAS CAUSING THE HANDPIECE TO RUN ON ITS OWN WITHOUT USER ACTIVATION. IT WAS REPORTED THAT THERE WAS NO ASSOCIATED PROCEDURE. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446573 TPS HANDPIECE CORD UNIT, OPERATIVE DENTAL EIA STRYKER INSTRUMENTS-KALAMAZOO 11224

    Patients

    Seq Age Sex Outcome Treatment
    1