BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVB1 CAMERA CONTROL UNIT

    MDR report key: 8429719 · Received March 18, 2019

    Report

    Report Number
    1221934-2019-56627
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 18, 2019
    Report Date
    February 18, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FWF
    UDI-DI
    10886705026180
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE AND REPAIR CENTER. PER SERVICE REPORT, THE REPORTED FAILURE WAS VERIFIED. HENCE, THIS COMPLAINT CAN BE CONFIRMED. DURING EVALUATION, IT WAS FOUND THAT THE CCU DISPLAY ON THE MONITOR GOES RED IN 1 HOUR AS WELL AS AFTER IN 3 HOURS. ADDITIONALLY, THE VIDEO 1/0 AND ISOLATION BOARD WERE REPLACED WHICH WERE DETERMINED TO BE THE ROOT CAUSE OF THE REPORTED FAILURE. THE DEVICE ALSO PASSED THE HI-POT TEST. THE DEVICE WAS RESTORED TO SPECIFICATION AND FUNCTIONS AS INTENDED. FURTHERMORE, A NON-CONFORMANCE SEARCH WAS CONDUCTED AND NO NON-CONFORMANCES WERE IDENTIFIED FOR THIS PART (242300) SERIAL NUMBER (B)(4) COMBINATION 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT DURING THE SURGERY BY USING OVB1 CCU AND TCK1 HD CAMERA HEAD, THE CAMERA STOPPED GIVING OUTPUT ON THE SCREEN. ADDITIONAL INFORMATION RECEIVED FORM THE AFFILIATE REPORTED THAT THE PROCEDURE WAS CANCELLED BECAUSE THE CAMERA DID NOT WORK AND AN ALTERNATIVE DEVICE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220848 OVB1 CAMERA CONTROL UNIT ENDOSCOPIC VIDEO IMAGE PROCESSOR FWF MEDOS INTERNATIONAL SARL 10886705026180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention