BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL-IN-ONE CCU+LIGHT ROW

    MDR report key: 10332316 · Received July 28, 2020

    Report

    Report Number
    1221934-2020-01941
    Event Type
    Malfunction
    Date Received
    July 28, 2020
    Report Date
    July 14, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FCW
    UDI-DI
    10886705028702
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. INVESTIGATION SUMMARY =THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. IT WAS REPORTED THAT ALL-IN-ONE CCU+LIGHT SOURCE HAD A BROKEN MONITOR. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. IT WAS FOUND DURING EVALUATION THAT THE FRONT BEZEL WAS DAMAGED. FURTHER, THE LCD WAS BROKEN AND MEMORY BACKUP BATTERY DAMAGED. THE LCD-DISPLAY, FRONT BEZEL PANEL AND MEMORY BACKUP BATTERY WERE REPLACED TO RESOLVE THE ISSUES. AFTER REPAIR, THE DEVICE WAS FOUND TO BE WORKING ACCORDING TO THE SPECIFICATIONS. THE PHYSICAL DAMAGE TO THE DEVICE IS MOST LIKELY DUE TO USER MISHANDLING OF THE DEVICE OR A POSSIBLE FALL. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [1801015] NUMBER, 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: UDI: (B)(4). AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE IN ITALY THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE, AN ALL-IN-ONE CCU+LIGHT SOURCE HAD A BROKEN MONITOR. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794886 ALL-IN-ONE CCU+LIGHT ROW ENDOSCOPIC VIDEO IMAGING SYSTEM FCW MEDOS INTERNATIONAL SARL 242302 10886705028702

    Patients

    Seq Age Sex Outcome Treatment
    1