BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER AC ZOOM

    MDR report key: 10684961 · Received October 15, 2020

    Report

    Report Number
    1221934-2020-03014
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    September 25, 2020
    Report Date
    September 28, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FEM
    UDI-DI
    10886705028634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE LOCKING SPRING WAS BROKEN, WAS CONFIRMED. THE FOLLOWING DEFECTS WERE FOUND DURING EVALUATION : ENDOSCOPE NOT ATTACHABLE, DAMAGED GRASPING MECHANISM, IMAGE DECENTERING. EXTERNAL DAMAGE OF ADJUSTING RINGS AND BLOCKED ZOOM OR FOCUS ADJUSTING RING. THE DAMAGED ENDOSCOPE GRASPING MECHANISM WAS REPLACED ALONG WITH THE ADJUSTING RINGS INCLUDING O RINGS AND MECHANICAL COMPONENT III RELATED TO THE ADJUSTING RINGS. THE DEVICE WAS TESTED AND FOUND TO BE WORKING ACCORDING TO SPECIFICATIONS. THE ROOT CAUSE OF THE DAMAGE TO THE DEVICE WAS IDENTIFIED TO BE DUE TO INCORRECT HANDLING OF THE DEVICE OR A PROBABLE FALL, DURING EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [SERIAL NUMBER : (B)(6)], 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. DEVICE HISTORY LOT: THE DEVICE MANUFACTURING HISTORY RECORD FOR CATALOG # 242436, SN (B)(6) INDICATES 7 DEVICES WERE MANUFACTURED WITH THE WORK ORDER AND ACCEPTED INTO FINAL STOCK IN FEB 2018 WITH NO REPORTED DISCREPANCIES.

    Additional Manufacturer Narrative · 1

    (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. UDI: (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE SALES REP VIA PHONE, THE LOCKING SPRING IS BROKEN. ANOTHER COUPLER WAS USED TO COMPLETE THE SHOULDER SURGERY WITH NO DELAY AND NO PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148771 COUPLER AC ZOOM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SàRL 242436 10886705028634

    Patients

    Seq Age Sex Outcome Treatment
    1