BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD COUPLER, C-MOUNT, 20MM

    MDR report key: 9832572 · Received March 14, 2020

    Report

    Report Number
    1221934-2020-00856
    Event Type
    Malfunction
    Date Received
    March 14, 2020
    Date of Event
    January 15, 2020
    Report Date
    March 13, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FEM
    UDI-DI
    10886705026272
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND INSPECTED VISUALLY. UPON VISUAL INSPECTION, IT WAS NOTICED THAT THE IN THE LOOP OF THE DEVICE IS BLURRY/NOT CLEAR. ITS POSSIBLY DUE TO MOISTURE OR FOREIGN SUBSTANCE IN IT. THE RECEIVED DEVICE WOULD NOT BE SERVICED AS THE PRODUCT CODE (242316) IS IN PROCESS TO BE OBSOLETE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR PART NO: 242316, SERIAL. NO: (B)(4), AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE CAN NOT BE TESTED FOR FUNCTIONALITY BUT WILL BE CONFIRMED BASED ON THE VISUAL INSPECTION. NO STRUCTURAL ANOMALIES WERE OBSERVED. BASED ON GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. AT THIS POINT, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP VIA EMAIL THAT DURING A SHOULDER SCOPE PROCEDURE THE COUPLER, C-MOUNT, 20 MM IS CLOUDY. THE PROCEDURE WAS COMPLETED WITH ANOTHER COUPLER WITH NO PATIENT HARM BUT THERE WAS A MINUTE SURGICAL DELAY TO THE CASE TO CHANGE OUT THE COUPLER. THE DEVICE WILL BE RETURNING FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296052 HD COUPLER, C-MOUNT, 20MM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SàRL 242316 10886705026272

    Patients

    Seq Age Sex Outcome Treatment
    1