BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD AC - C-MOUNT

    MDR report key: 14644140 · Received June 9, 2022

    Report

    Report Number
    1221934-2022-01707
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    April 29, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FWF
    UDI-DI
    10886705028733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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. UDI: (B)(4). INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: MINOR SCRATCHES ON THE DEVICE. POOR IMAGE CONTROLS. CAMERA HEAD : BROKEN CONNECTOR PIN. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. THE REPAIR OF THE DEVICE WAS HOWEVER DECLINED, AND IT IS BEING PLACED INTO LONG TERM HOLD. AS PART OF DEPUY MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE FAULTY PARTS WAS IDENTIFIED AS THE ROOT CAUSE FOR THE DEVICE FAILURE DURING THE SERVICE EVALUATION. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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 SALES REP THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON 4/29/2022, IT WAS OBSERVED THAT THE CAMERA HEAD AC - C-MOUNT DEVICE WAS SHOWING DOUBLE PICTURE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CAMERA HEAD ON THE DEVICE HAD BROKEN CONNECTOR PIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679011 CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SARL 242401 10886705028733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown