BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, ANGLED

    MDR report key: 10437134 · Received August 21, 2020

    Report

    Report Number
    1037007-2020-00035
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Report Date
    September 22, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS MORE INFORMATION ON THE DEVICE EVALUATION. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. THE DEVICE HISTORY RECORDS (DHR) FOR THIS DEVICE HAVE BEEN REVIEWED. ALL RECORDS INDICATE THAT THE DEVICE WAS MANUFACTURED, TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES, AND MET ALL FINAL PRODUCT RELEASE CRITERIA. A TOTAL OF FIVE UNITS WERE PRODUCED UNDER THIS JOB NUMBER WITH NO ASSOCIATED NCRS, REPORTED SCRAP, OR RECORDED PROCESS DEVIATIONS RELATING TO THE REPORTED FAILURE. THE OLYMPUS SERVICE TEAM RECEIVED THE DEVICE FOR THE REPORTED ISSUE OF HAND-PIECE ERROR ADVISING IT SHOULD BE REPLACED. A VISUAL INSPECTION WAS PERFORMED. THERE WERE NO ABNORMALITIES FOUND ASIDE FROM COSMETIC DAMAGES TYPICAL OF WEAR AND TEAR. FURTHERMORE, FUNCTIONAL TESTS WERE PERFORMED TO ASSESS DEVICE STATUS. IT WAS FOUND TO FAIL THE BREAKOUT BOX TEST INTERMITTENTLY DUE TO A SHORT BETWEEN HALL A/B/C WIRE SHORT. THE ROOT CAUSE OF HAND-PIECE NOT FUNCTIONING AS INTENDED WAS CONFIRMED. THE DAMAGES CONFIRMED WERE A SHORT BETWEEN HALL A/B/C WIRE, RESULTING IN HAND-PIECE WORKING INTERMITTENTLY. PER (B)(4) DIEGO ELITE FUNCTIONAL CHECKLIST. A HAND-PIECE IS OPERATED WITH A TEST CONSOLE AND APPROPRIATE ACCESSORIES FOR USABILITY. THIS SUGGESTS THAT THE HAND-PIECE WAS SHIPPED FREE FROM DAMAGES. THE DAMAGES INCURRED WERE LIKELY DURING USE OR TRANSPORTATION.

    Additional Manufacturer Narrative · 1

    DUE DILIGENCE WAS EXECUTED FOR THIS EVENT. EVENT DATE IS NOT KNOWN. SUPPLEMENTAL REPORT(S) WILL BE FILED AS ANY INFORMATION BECOMES AVAILABLE. THE DEVICE HAS BEEN RETURNED AND A DEVICE EVALUATION COMPLETED FOR IT. THE MANUFACTURE DATE IS NOT AVAILABLE. UPON INSPECTION, THE DEVICE FAILED BREAKOUT BOX TEST INTERMITTENTLY. THE UNIT FAILED GND-PHASE A, GND-PHASE B AND GND-PHASE C. AS SUCH, THE DEVICE COULD NOT BE CONNECTED TO CONSOLE TO TEST FURTHER FOR THE ERROR MESSAGE.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, JUST AS THE THERAPEUTIC PROCEDURE WAS ABOUT TO START, THE DEVICE DID NOT WORK WITH OBSERVED ERROR MESSAGE: HANDPIECE ERROR. UNPLUG HANDPIECE AND RECONNECT. IF PROBLEM PERSISTS, REPLACE HANDPIECE. THE CONNECTION WAS SECURE AND THERE WAS NO VISUAL DEFECT TO THE DEVICE OBSERVED. THE ISSUE PERSISTED EVEN WITH DIFFERENT CONSOLES. THE SURGEON USED A DIFFERENT DEVICE AND COMPLETED THE PROCEDURE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900377 MULTIDEBRIDER HANDPIECE, ANGLED ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI GYRUS ACMI, INC MDHP100A

    Patients

    Seq Age Sex Outcome Treatment
    1