BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPS HANDPIECE CORD

    MDR report key: 2851330 · Received October 29, 2012

    Report

    Report Number
    1811755-2012-03906
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    HRX
    PMA / PMN Number
    K943323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A TPS HANDPIECE CORD WAS SENT FOR EVALUATION BECAUSE IT WAS CAUSING HANDPIECES TO RUN WITHOUT ACTIVATION DURING PERFORMANCE TESTING. THE EVENT OCCURRED DURING A ROUTINE FIELD SERVICE MAINTENANCE VISIT. THERE WAS NO PT INVOLVEMENT; NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPS HANDPIECE CORD HRX STRYKER INSTRUMENTS KALAMAZOO 07025

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK