BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD AC - C-MOUNT

    MDR report key: 14580355 · Received June 2, 2022

    Report

    Report Number
    1221934-2022-01586
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 13, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FWF
    UDI-DI
    10886705028733
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UDI: (B)(4). THE SERIAL NUMBER WAS UNKNOWN. THE SERIAL NUMBER WAS UNKNOWN; THEREFORE, THE MANUFACTURING SITE NAME AND DEVICE MANUFACTURE DATE WERE UNKNOWN. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SHOULD THE DEVICE EVER BE RECEIVED BACK IN THE FUTURE, THIS COMPLAINT FILE WILL BE REOPENED AT THAT TIME AND AN EVALUATION WILL BE PERFORMED AND DOCUMENTED. NO SERIAL NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT OF SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AS PART OF DEPUY MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. WITH THE INFORMATION PROVIDED, AND WITHOUT THE COMPLAINT DEVICE TO EVALUATE, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. 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. DEVICE HISTORY LOT: NO SERIAL NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT OF SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING A MENISCAL REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT NOISES APPEARED ON THE MONITOR AND THE RECORDING STARTED UNINTENTIONALLY. ACCORDING TO THE REPORT, BOTH EVENTS TOOK PLACE OVER AND OVER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH LESS THAN 30-MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819249 CAMERA HEAD AC - C-MOUNT ENDOSCOPIC VIDEO CAMERA FWF MEDOS INTERNATIONAL SARL 242401 10886705028733

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown