BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD AC - C-MOUNT

    MDR report key: 9957975 · Received April 14, 2020

    Report

    Report Number
    1221934-2020-01152
    Event Type
    Malfunction
    Date Received
    April 14, 2020
    Date of Event
    January 1, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FWF
    UDI-DI
    10886705028733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE DEVICE HAD A DAMAGED CONNECTOR WAS CONFIRMED. IT WAS FURTHER FOUND DURING TESTING THAT THE DEVICE DISPLAYED THE LIVE VIDEO INTERMITTENTLY. THE DEVICE WAS HOWEVER FOUND TO BE IRREPARABLE AND WAS SENT BACK WITHOUT REPAIR AS PER THE INSTRUCTIONS FROM THE CUSTOMER. THE DAMAGED CONNECTOR IS RESPONSIBLE FOR THE INTERMITTENT OPERATION OF THE DEVICE. THE DEVICE MANUFACTURING HISTORY RECORD FOR CATALOG #242401, SN : (B)(4) INDICATES 9 DEVICES WERE MANUFACTURED WITH THE WORK ORDER AND ACCEPTED INTO FINAL STOCK IN (B)(6) 2019 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA SERVICE REQUEST THAT BEFORE AN UNKNOWN PROCEDURE THE CONNECTOR OF THE CAMERA HEAD AC - C-MOUNT WAS DEFECTIVE. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423733 CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SàRL 242401 10886705028733

    Patients

    Seq Age Sex Outcome Treatment
    1