BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, ANGLED

    MDR report key: 10546532 · Received September 17, 2020

    Report

    Report Number
    1037007-2020-00045
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Report Date
    October 13, 2020
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K123429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE RETURN EVALUATION, REVIEW OF THE DEVICE HISTORY RECORDS (DHR). 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. THE OLYMPUS SERVICE TEAM RECEIVED A MDHP100A FOR THE REPORTED ISSUE OF YELLOW ERROR. VISUAL INSPECTION WAS PERFORMED. THERE WERE NO DISCERNIBLE DAMAGES FOUND ASIDE FROM COSMETIC WEAR AND TEAR. FUNCTIONAL TESTS WERE PERFORMED ON THE DEVICE AND FOUND TO HAVE FAILED THE BREAKOUT BOX TEST FOR GND-HALL A, GND-HALL B, AND GND-HALL C. IT ALSO FAILED THE 5V-GND TEST. THOUGH THE USER REQUEST COULD NOT BE CONFIRMED, THE MDHP100A IS TESTED WITH A TEST CONSOLE AND APPROPRIATE ACCESSORIES (BLADE AND TUBESET) AT SPECIFIC SETTINGS TO ASSURE PROPER ACTIVATION AND PAIRING. DUE TO THE FUNCTIONAL CHECKLIST AND DHR, IT IS LIKELY THAT THE HANDPIECE WAS SHIPPED FREE FROM DAMAGES. THIS SUGGEST THAT THE DAMAGES INCURRED WERE LIKELY DURING TRANSPORTATION OR USE. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED AND EVALUATED. EVALUATION DETERMINED THAT THE YELLOW ERROR CODE REPORTED WAS NOT DUPLICATED DURING THE DEVICE TESTING, HOWEVER, THE DEVICE FAILED TO CONNECT TO CONSOLE DUE TO FAILED BREAKOUT BOX TEST. ADDITIONALLY, THE HOUSING WAS OBSERVED WITH COSMETIC DAMAGE DUE TO NORMAL WEAR AND TEAR. THE DEVICE WAS PLACED FOR REPAIR. REPORTED FAILURE OF YELLOW ERROR CODE WAS NOT ABLE TO BE DUPLICATED, HOWEVER, A FAILED BOX TEST WAS OBSERVED. THE ROOT CAUSE TO THE REPORTED FAILURE OF THE USER IS UNKNOWN. LIKELY PROBABLE CAUSE WAS DUE TO A FAILED BREAKOUT BOX TEST THAT LIKELY CONTRIBUTED TO THE REPORTED FAILURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE DEVICE EXHIBITED YELLOW ERROR CODE, NOT FUNCTIONING AND WAS REPLACED. NO FURTHER DETAILS PROVIDED REGARDING THE REPORTED EVENT. NO PATIENT HARM OR IMPACT WAS REPORTED. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013581 MULTIDEBRIDER HANDPIECE, ANGLED MULTIDEBRIDER HANDPIECE, ANGLED GEI GYRUS ACMI, INC MDHP100A

    Patients

    Seq Age Sex Outcome Treatment
    1