BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE CCU+LIGHT ROW

    MDR report key: 11797035 · Received May 10, 2021

    Report

    Report Number
    1221934-2021-01470
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 22, 2021
    Report Date
    April 23, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FCW
    UDI-DI
    10886705028702
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY A ALL-IN-ONE CCU+LIGHT SOURCE PRESENTED INTERMITTENT ISSUES WITH THE CAMERA BOX GENERATING AN IMAGE WHEN THE CAMERA IS PLUGGED IN. THEY REQUIRED A HARD REBOOT TO GET IT TO START WORKING AGAIN AND CASE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 5 MINUTES. PER SERVICE MANUAL OPERATIONAL AND DIAGNOSTIC, NO DEFECT WAS FOUND WITH THE DEVICE, THEREFORE THIS COMPLAINT CANNOT BE CONFIRMED. AS THE REPORTED PROBLEM WAS NOT CONFIRMED AND NO DEFECTS IDENTIFIED, A ROOT CAUSE FOR THE ISSUE THAT WAS EXPERIENCED BY THE USER CANNOT BE DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1812007] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER ARTHROSCOPY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ALL-IN-ONE CCU+LIGHT SOURCE DEVICE PRESENTED INTERMITTENT ISSUES WITH THE CAMERA BOX GENERATING AN IMAGE WHEN THE CAMERA WAS PLUGGED IN. ACCORDING TO THE REPORT, THE DEVICE REQUIRED A HARD REBOOT TO GET IT TO START WORKING AGAIN. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694203 ALL-IN-ONE CCU+LIGHT ROW ENDOSCOPIC VIDEO IMAGING SYSTEM FCW MEDOS INTERNATIONAL SARL 242302 10886705028702

    Patients

    Seq Age Sex Outcome Treatment
    1