BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD AC - C-MOUNT

    MDR report key: 14194358 · Received April 25, 2022

    Report

    Report Number
    1221934-2022-01205
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FWF
    UDI-DI
    10886705028733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: FUNCTIONAL : INTERMITTENT OPERATION CABLE THE REPAIR OF THE DEVICE WAS HOWEVER DECLINED AND WAS RETURNED TO THE CUSTOMER UNREPAIRED. THE ROOT CAUSE FOR THE DEVICE FAILURE COULD NOT BE DETERMINED DURING THE SERVICE EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE SERIAL NUMBER (B)(4). AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    IT WAS REPORTED BY THE AFFILIATE IN CHILE THAT THE VIDEO ON THE CAMERA HEAD AC - C-MOUNT DEVICE WAS NOT WORKING WHEN THE CABLE WAS HANDLED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE HAD INTERMITTENT OPERATION IN THE CABLE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    952876 CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SARL 242401 10886705028733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown