BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSOLE 110V(PEDAL&POLE INCLD)

    MDR report key: 4121187 · Received September 26, 2014

    Report

    Report Number
    0008043928-2014-00020
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 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

    DURING FAILURE ANALYSIS, THE REPORTED EVENT OF THE IRRIGATION PUMP NOT WORKING WAS DUPLICATED DURING SERVICE EVALUATION. THE DEVICE WAS FOUND TO HAVE MECHANICAL DAMAGE TO THE IRRIGATION PINCH VALVE ASSEMBLY, THE PANEL HOUSING, AND VIBRATION SOUND MOUNTS. THIS MECHANICAL DAMAGE CAN BE THE RESULT OF HANDLING THE DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONOPET CONSOLE 110V (PEDAL AND POLE INCLUDED) HAD A BROKEN IRRIGATION PUMP. THE DEVICE WAS BEING USED AS A MARKETING SAMPLE. DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY, IT WAS CLARIFIED THAT THE IRRIGATION PINCH VALVE WAS NOT WORKING PRESENTING A CONDITION WHERE THE DEVICE HAS THE POTENTIAL TO OVERHEAT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SONOPET CONSOLE 110V (PEDAL AND POLE INCLUDED) HAD A BROKEN IRRIGATION PUMP. THE DEVICE WAS BEING USED AS A MARKETING SAMPLE. DURING SERVICE INSPECTION AT THE MANUFACTURING FACILITY, IT WAS CLARIFIED THAT THE IRRIGATION PINCH VALVE WAS NOT WORKING PRESENTING A CONDITION WHERE THE DEVICE HAS THE POTENTIAL TO OVERHEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601543 CONSOLE 110V(PEDAL&POLE INCLD) INSTRUMENT, ULTRASONIC SURGICAL LFL STRYKER INSTRUMENTS-INAGI

    Patients

    Seq Age Sex Outcome Treatment
    1