BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, STRAIGHT

    MDR report key: 10447892 · Received August 25, 2020

    Report

    Report Number
    1037007-2020-00037
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Report Date
    September 29, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    KMW
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE DEVICE EVALUATION RESULTS. DUE TO NO DEVICE RETURNED, AN INVESTIGATION INTO THE DEVICE STATUS WAS NOT POSSIBLE AT THIS MOMENT. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THE INVESTIGATION SHALL BE UPDATED APPROPRIATELY. DUE TO NO DEVICE RETURN A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PER F210300 DIEGO ELITE MDU FUNCTIONAL CHECKLIST, A MDHP100S IS VISUALLY AND FUNCTIONALLY INSPECTED WITH A TEST CONSOLE. PROPER MOTOR ACTIVATION AND RF ENERGY IS VERIFIED OVER 10 SECONDS WITH ALL APPROPRIATE ACCESSORIES. THE FUNCTIONAL CHECKLIST AND DEVICE HISTORY RECORD SUGGESTS THAT THE DEVICE WAS SHIPPED FREE FROM DAMAGES. THIS MAY MEAN THAT THE DAMAGES INCURRED WERE AS A RESULT OF TRANSPORTATION OR USE. THE DEVICE HISTORY REVIEW (DHR) SHOWED A MANUFACTURING AND QUALITY CONTROL REVIEW WAS PERFORMED FOR THE AFFECTED SERIAL/LOT NUMBER WITHOUT SHOWING ANY NON-CONFORMITIES OR DEVIATIONS REGARDING THE DESCRIBED ISSUES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE USER¿S COMPLAINT WAS NOT CONFIRMED. NO FINDINGS AVAILABLE. THE CAUSE COULD NOT BE DETERMINED. NO FURTHER INFORMATION WAS REPORTED. A SUPPLEMENTAL WILL BE SUBMITTED IF NEW INFORMATION BECOMES AVAILABLE OR THE DEVICE IS RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE DEVICE WAS EXPERIENCING OVERHEATING OF THE HANDPIECE. THE HANDPIECE WAS OPERATING INTERMITTENTLY WHEN IT WAS STARTING AND STOPPING DURING USE, THEN IT BECAME HOT. THERE WAS NO PATIENT INJURY OR HARM REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916742 MULTIDEBRIDER HANDPIECE, STRAIGHT HANDPIECE KMW GYRUS ACMI, INC MDHP100S

    Patients

    Seq Age Sex Outcome Treatment
    1