BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, ANGLED

    MDR report key: 11689371 · Received April 19, 2021

    Report

    Report Number
    1037007-2021-00027
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Report Date
    April 19, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    UDI-DI
    00821925027749
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED. INSPECTION FOUND THE DEVICE FAILED THE GND-A, GND-B, AND GND-C BREAKOUT BOX TEST, THE HANDPIECE WAS FOUND FAULTY. THE REPORTED ISSUE WAS CONFIRMED. THE DEFINITIVE ROOT CAUSE WAS CONFIRMED TO BE AS A RESULT OF THE FAILED GND-PHASE BREAKOUT BOX TEST. THE RESULT OF THIS DAMAGE IS THE HANDPIECE WORKING INTERMITTENTLY. THE DEVICE HISTORY RECORDS (DHRS) FOR THIS PRODUCT HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE PRODUCT WAS MANUFACTURED, TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES, AND MET ALL FINAL PRODUCT RELEASE CRITERIA. PER THE DEVICE FUNCTIONAL CHECKLIST, THE HANDPIECE MUST UNDERGO AN ACTIVATION TEST WITH THE APPROPRIATE CONSOLE AND ACCESSORIES PRIOR TO BEING SHIPPED OUT. THEREFORE, IT IS IMPROBABLE FOR THE HANDPIECE TO BE SHIPPED OUT TO THE CUSTOMER WITH A KNOWN ACTIVATION/RECOGNITION ISSUE. THE DAMAGES INCURRED WERE LIKELY AS A RESULT OF TRANSPORTATION OR CUSTOMER USE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE THROUGH REGULAR TRENDING ACTIVITIES.

    Description of Event or Problem · 1

    COMMUNICATION ERROR WITH HAND PIECE WAS REPORTED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583315 MULTIDEBRIDER HANDPIECE, ANGLED MULTIDEBRIDER HANDPIECE, ANGLED GEI GYRUS ACMI, INC MDHP100A 00821925027749

    Patients

    Seq Age Sex Outcome Treatment
    1