BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER AC ZOOM

    MDR report key: 10276055 · Received July 15, 2020

    Report

    Report Number
    1221934-2020-01828
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    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
    MA, US
    Reporter Occupation
    OTHER

    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 WILL NOT ZOOM AND CANNOT BE FOCUSED, WAS CONFIRMED. THE DEVICE WAS TESTED AND FOUND THAT THE DEVICE HAD PRESENCE OF FOREIGN MATTER / PRECIPITATE. FURTHER, IT WAS FOUND THAT THE DEVICE COULD NOT FOCUS DUE TO A BLOCKED ZOOM OR FOCUS ADJUSTING RING. ALSO, THE GRASPING MECHANISM AND IMAGE DECENTERING WERE DAMAGED AND THE ADJUSTING RINGS WERE EXTERNALLY DAMAGED. THE ENDOSCOPE GRASPING MECHANISM, ALONG WITH BOTH ADJUSTING RINGS INCLUDING O-RING SEALS AND THE INTERNAL MECHANICAL COMPONENT RELATED TO ADJUSTING RINGS 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 : B000523 INDICATES 10 DEVICES WERE MANUFACTURED WITH THE WORK ORDER AND ACCEPTED INTO FINAL STOCK IN MAR 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

    THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY AN EMPLOYEE THAT POST-OP TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT TWO WOULD NOT ZOOM AND COULD NOT BE FOCUSED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD 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
    741232 COUPLER AC ZOOM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SARL 242436 10886705028634

    Patients

    Seq Age Sex Outcome Treatment
    1