BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2991500 · Received March 6, 2013

    Report

    Report Number
    0001811755-2013-00457
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    HWE
    PMA / PMN Number
    K032117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMMENT THAT THE CABLE OVERHEATED COULD NOT BE CONFIRMED DURING SIMULATED USE TESTING. IT WAS FOUND DURING TESTING THAT THERE WERE INTERNAL WIRE BREAKS OF THE CABLE, THIS COULD HAVE CAUSED INTERMITTENT OVERHEATING IF THE CABLE WAS USED FOR AN EXTENDED PERIOD OF TIME, ALTHOUGH THIS COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE DEVICE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPS HANDPIECE CORD WAS OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT, NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TPS HANDPIECE CORD WAS OVERHEATING DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT INCIDENT, NO ADVERSE CONSEQUENCE WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96191 TPS HANDPIECE CORD INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT HWE STRYKER INSTRUMENTS-KALAMAZOO 09356

    Patients

    Seq Age Sex Outcome Treatment
    1