BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD AC - C-MOUNT

    MDR report key: 19849861 · Received July 29, 2024

    Report

    Report Number
    1221934-2024-02588
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    May 16, 2024
    Report Date
    July 29, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FWF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. 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. H11 ADDITIONAL NARRATIVE: H4: UNKNOWN INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: FUNCTIONAL: INTERMITTENT OPERATION PER SERVICE REPORTS, THIS COMPLAINT CANNOT BE CONFIRMED. 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 THAT DURING AN IN HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE CAMERA HEAD AC - C-MOUNT DEVICE HAD INTERMITTENT OPERATION. IT WAS NOTED IN THE SERVICE ORDER THAT THE CAMERA CORD WAS GRITTY AND NOT CLOSING PROPERLY. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015231 CAMERA HEAD AC - C-MOUNT CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO FWF MEDOS INTERNATIONAL SàRL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown