BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL HANDPIECE

    MDR report key: 4192582 · Received October 22, 2014

    Report

    Report Number
    0008043928-2014-00023
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    STRYKER INSTRUMENTS-INAGI
    Product Code
    LFL
    PMA / PMN Number
    K010309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED. A FOLLOW-UP WILL BE SUBMITTED ONCE THE DEVICE IS RECEIVED AND THE QUALITY INVESTIGATION IS COMPLETE. DEVICE RETURN EXPECTED, BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    NO DEVICE EVALUATION WILL BE PERFORMED; THEREFORE, NO ROOT CAUSE CAN BE IDENTIFIED. DEVICE NOT RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONOPET UNIVERSAL HANDPIECE WAS HEATING UP DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. ADDITIONALLY, IT WAS REPORTED THAT THE IRRIGATION WAS WORKING CORRECTLY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONOPET UNIVERSAL HANDPIECE WAS HEATING UP DURING THE COURSE OF A PROCEDURE AT THE USER FACILITY. ADDITIONALLY, IT WAS REPORTED THAT THE IRRIGATION WAS WORKING CORRECTLY. NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION, AND NO SURGICAL DELAY WERE REPORTED WITH THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671750 UNIVERSAL HANDPIECE INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1