BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD COUPLER, C-MOUNT, 20MM

    MDR report key: 9758330 · Received February 26, 2020

    Report

    Report Number
    1221934-2020-00684
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    February 12, 2020
    Report Date
    February 12, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FEM
    UDI-DI
    10886705026272
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. H10 ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION: INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND INSPECTED VISUALLY. UPON VISUAL INSPECTION, DUST/BLACK PARTICLE WAS NOTICED IN THE LOOP OF THE DEVICE. THE RECEIVED DEVICE WOULD NOT BE SERVICED AS THE PRODUCT CODE (242316) IS IN PROCESS TO BE OBSOLETED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR PART NO: 242316 -SERIAL. NO: (B)(6) AND NO NON-CONFORMANCES WERE IDENTIFIED. THE DEVICE CAN NOT BE TESTED FOR FUNCTIONALITY AS CAMERA HEAD WAS NOT RETURNED BUT COMPLAINT WILL BE CONFIRMED BASED ON THE VISUAL INSPECTION. NO STRUCTURAL ANOMALIES WERE OBSERVED. BASED ON GIVEN THE INFORMATION PROVIDED WE CANNOT DISCERN A DEFINITIVE ROOT CAUSE FOR THE REPORTED FAILURE. AT THIS POINT, 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 HISTORY REVIEW: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR PART NO: 242316 -SERIAL. NO: (B)(6) AND NO NON-CONFORMANCES WERE IDENTIFIED

    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. 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. H10 ADDITIONAL NARRATIVE: D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. 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

    PRODUCT COMPLAINT #: (B)(4). UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY SALES REP VIA EMAIL, THAT WHILE CLEANING A COUPLER, C-MOUNT, 20 MM AND A CAMERA HEAD AC, C-MOUNT, THE COUPLER BROKE OFF IN THE CAMERA HEAD. NO SURGICAL DELAY OR PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT DID NOT OCCUR DURING STERILE PROCESSING, FILED INSPECTION, OR INTERNAL SERVICE ACTIVITIES. THE AFFILIATE WAS ALSO ABLE TO CONFIRM SURGICAL INTERVENTION IS NOT PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217225 HD COUPLER, C-MOUNT, 20MM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SàRL 242316 10886705026272

    Patients

    Seq Age Sex Outcome Treatment
    1