BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2233152 · Received July 22, 2011

    Report

    Report Number
    1811755-2011-02642
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISASSEMBLY OF THE DEVICE, A BROKEN WIRE WAS NOTED. THE WIRE WAS BROKEN AT THE POINT WHERE CABLE ENTERS THE STRAIN RELIEF AT THE HANDPIECE END. THE BROKEN WIRE WAS IDENTIFIED AS THE PROBABLE CAUSE OF THE FAILURE DESCRIBED. THE DEVICE WAS DISCARDED BECAUSE IT IS NOT A REPAIRABLE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPS HANDPIECE CORD CAUSED AN ATTACHED HAND PIECE TO RUN BY ITSELF WITHOUT ACTIVATION. THE EVENT OCCURRED DURING A ROUTINE MAINTENANCE VISIT. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD HWE STRYKER INSTRUMENTS KALAMAZOO 08268

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK