BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, ANGLED

    MDR report key: 10267934 · Received July 13, 2020

    Report

    Report Number
    1037007-2020-00020
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 17, 2020
    Report Date
    August 25, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GIE
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, REVIEW OF THE DEVICE HISTORY RECORDS (DHR) AND DEVICE EVALUATION. THE DEVICE HISTORY RECORDS FOR THIS DEVICE WERE REVIEWED AND ALL RECORDS INDICATED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO ALL APPLICABLE PROCEDURES AND MET FINAL PRODUCT RELEASE CRITERIA. NO ABNORMALITIES WERE FOUND. IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE HANDPIECE MDHP100A FOUND NO ACTIVATION. THE MDHP100A WAS RECEIVED FOR THE REPORTED ISSUE OF NOT ACTIVATING. THE HANDPIECE WAS VISUALLY INSPECTED. THERE WERE NO DISCERNIBLE ABNORMALITIES FOUND. IN ADDITION, FUNCTIONAL TESTING WAS PERFORMED. THE HANDPIECE PASSED ALL FUNCTIONAL TESTS, THE SERVICE TEAM WAS UNABLE TO DUPLICATE THE USER REPORTED FAILURE. DUE TO NO DAMAGES CONFIRMED, A ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR USE THE DEVICE HANDPIECE MDHP100A FOUND NO ACTIVATION. ACCORDING TO THE REPORTER, THE BURR UNIT WAS REMOVED AND WAS REATTACHED HOWEVER, THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS REPLACED WITH ANOTHER HANDPIECE AND NO OTHER FURTHER DETAILS REGARDING THE EVENT WAS PROVIDED. NO PATIENT INVOLVEMENT ON THIS EVENT, NO USER HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726506 MULTIDEBRIDER HANDPIECE, ANGLED OLYMPUS ENERGY POWER SYSTEM (EPS) GIE GYRUS ACMI, INC MDHP100A

    Patients

    Seq Age Sex Outcome Treatment
    1