BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER AC ZOOM

    MDR report key: 10276089 · Received July 15, 2020

    Report

    Report Number
    1221934-2020-01829
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    November 5, 2019
    Report Date
    July 9, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FEM
    UDI-DI
    10886705028634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE COUPLER AC ZOOM WAS BLURRY, WAS CONFIRMED. THE DEVICE WAS TESTED AND FOUND THAT THE DEVICE COULD NOT FOCUS DUE TO THE PRESENCE OF FOREIGN MATTER / PRECIPITATE. ALSO, THE GRASPING MECHANISM AND IMAGE DECENTERING WERE DAMAGED. FURTHER, THE ADJUSTING RINGS WERE EXTERNALLY DAMAGED. THE ENDOSCOPE GRASPING MECHANISM, ALONG WITH BOTH ADJUSTING RINGS INCLUDING O-RING SEALS WERE EXCHANGED, THE DEVICE WAS REPAIRED, TESTED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. THE CAUSE OF THE IDENTIFIED FAILURES WERE IDENTIFIED BY THE SUPPLIER TO BE INCORRECT HANDLING OF THE DEVICE AND A POSSIBLE FALL. THE DEVICE MANUFACTURING HISTORY RECORD FOR CATALOG # 242436, SN : B000177 INDICATES 31 DEVICES WERE MANUFACTURED WITH THE WORK ORDER AND ACCEPTED INTO FINAL STOCK IN JAN 2018 WITH NO REPORTED DISCREPANCIES. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A SHOULDER ARTHROSCOPY, IT WAS OBSERVED THAT THE COUPLER AC ZOOM WAS BLURRY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY WITHOUT DELAY. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WOULD NOT FOCUS DUE TO THE PRESENCE OF FOREIGN MATTER / PRECIPITATE. THERE WERE NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742437 COUPLER AC ZOOM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SARL 242436 10886705028634

    Patients

    Seq Age Sex Outcome Treatment
    1