BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER AC ZOOM

    MDR report key: 13027683 · Received December 17, 2021

    Report

    Report Number
    1221934-2021-03818
    Event Type
    Malfunction
    Date Received
    December 17, 2021
    Date of Event
    October 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    FEM
    UDI-DI
    10886705028634
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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: H4: THE DEVICE MANUFACTURE DATE WAS REPORTED AS UNKNOWN ON THE INITIAL REPORT; AND HAS BEEN UPDATED ACCORDINGLY. INVESTIGATION SUMMARY: ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT DURING OPERATION, WHEN USE THE DEVICE FOR THE FIRST TIME, NOTICED THERE WAS SOME FOG ON THE COUPLER LENS. CHANGED ANOTHER TWO TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION, HOWEVER AN ARTHROSCOPIC IMAGE OF THE DEVICE WAS PROVIDED. UPON VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE IMAGE IS FOGGY AS REPORTED BY THE CUSTOMER, HOWEVER, THE CUSTOMER DID NOT REPORT WHICH DEVICE THE PHOTO BELONGS TO. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE B002171 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE VISUAL INSPECTION OF THE PHOTO, AND CONSIDERING THAT THE DEVICE WAS NOT SENT FOR SERVICE, THIS COMPLAINT CANNOT BE CONFIRMED. THE DEVICE IS REQUIRED FOR TESTING, THE PHOTO PROVIDED DOES NOT CONTAIN ENOUGH EVIDENCE TO DETERMINE WHY THE CUSTOMER EXPERIENCED THE FAILURE, HANDS ON ANALYSIS SHOULD PROVIDE THE REQUIRED EVIDENCE TO PROVIDE A ROOT CAUSE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO MONITOR ADDITIONAL COMPLAINT INFORMATION FOR POTENTIAL SAFETY SIGNALS THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 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 · 0

    IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A DIAGNOSTIC ARTHROSCOPY OF THE KNEE PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THE LENS ON THE COUPLER AC ZOOM DEVICE WERE FOGGING-UP. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925938 COUPLER AC ZOOM ENDOSCOPE CAMERA ADAPTOR FEM MEDOS INTERNATIONAL SARL 242436 10886705028634

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown