BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 4001094 · Received August 12, 2014

    Report

    Report Number
    0008043928-2014-00008
    Event Type
    Malfunction
    Date Received
    August 12, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE DEVICE SERIAL NUMBER WAS CORRECTED. DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE HANDPIECE OVERHEATING WAS DUPLICATED AND CONFIRMED DURING SERVICE EVALUATION WHEN THE GRIP OF THE HANDPIECE WAS FOUND TO OVERHEAT. THE GRIP OF THE HANDPIECE CAN OVERHEAT DUE TO A DEGRADING PZT CRYSTAL IN THE HANDPIECE. THE DEGRADATION INCREASES THE INTERNAL RESISTANCE OF THE DEVICE CAUSE THE HEAT. PER THE ACCOUNT, THE DEVICE WAS RETURNED TO THE USER FACILITY WITHOUT REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL HANDPIECE WAS OVERHEATING DURING A MANUFACTURER DEMONSTRATION. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIVERSAL HANDPIECE WAS OVERHEATING DURING A MANUFACTURER DEMONSTRATION. NO PATIENT INVOLVEMENT, NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480311 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1