BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDEBRIDER HANDPIECE, ANGLED

    MDR report key: 10556368 · Received September 18, 2020

    Report

    Report Number
    1037007-2020-00047
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Report Date
    February 3, 2021
    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 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 ROOT CAUSE OF THE REPORTED ISSUE WAS NOT IDENTIFIED AS THE DEVICE WAS NOT RETURNED TO THE OEM (ORIGINAL EQUIPMENT MANUFACTURER) FOR EVALUATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. IF THE DEVICE BECOMES AVAILABLE AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY WITH THE FINDINGS OF THE INSPECTION. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. THE FOLLOWING SECTIONS WERE UPDATED: D4, D10, G4, G7, H2,H3, H6, AND H10. THE DEVICE WAS RETURNED TO THE OEM (ORIGINAL EQUIPMENT MANUFACTURER) FOR EVALUATION. EVALUATION NOTED THAT THE UNIT FAILED FOR GND-PHASE A , GND-PHASE B AND GND-PHASE C WITH BREAKOUT BOX TEST. A REVIEW OF DEVICE HISTORY RECORDS PROVIDES NO SUGGESTION THAT THE MANUFACTURING PROCESS CONTRIBUTED TO THE PROPOSED REPORTED FAILURE AS THE DEVICE MET ALL FINAL RELEASE CRITERIA PRIOR TO SHIPMENT. THIS INCLUDES PASSING FUNCTIONAL CHECKS AS LISTED IN THE INSPECTION PROCEDURE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION, HOWEVER, THE DEVICE EVALUATION IS STILL PENDING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS NOT FUNCTIONING AS INTENDED, AND EXHIBITED "NOT RECOGNIZED ISSUE. "NO FURTHER DETAILS REPORTED REGARDING THE EVENT. NO PATIENT INVOLVEMENT REPORTED. NO USER HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016360 MULTIDEBRIDER HANDPIECE, ANGLED MULTIDEBRIDER HANDPIECE, ANGLED GEI GYRUS ACMI, INC MDHP100A

    Patients

    Seq Age Sex Outcome Treatment
    1