BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COUPLER AC FFL 19

    MDR report key: 18908526 · Received March 14, 2024

    Report

    Report Number
    1221934-2024-00868
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    March 12, 2024
    Report Date
    March 14, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    FEM
    UDI-DI
    10886705028610
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H10 ADDITIONAL NARRATIVE: H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. E3: REPORTER IS A J&J SALES REPRESENTATIVE. D10: CONCOMITANT MED PRODUCTS AND THERAPY DATES: 4K C-MNT SCP,4.0,30 ,167 DEVICE, CAMERA HEAD AC - C-MOUNT DEVICE, HD EPSCP,1.9,30,60,CW_STORZ DEVICE, COUPLER AC FFL 19 DEVICE; ON (B)(6) 2024 . AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. (B)(4)

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H10 ADDITIONAL NARRATIVE: H4: THE DEVICE MANUFACTURE DATE WAS UNAVAILABLE IN THE INITIAL MEDWATCH REPORT. THE DEVICE MANUFACTURE DATE HAD BEEN IDENTIFIED AND UPDATED ACCORDINGLY.

    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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11: ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY THE COMPLAINT DEVICE WAS RECEIVED AT THE SERVICE CENTER AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: DESCRIPTION OF FAULT ACCORDING TO WOM TECHNICIAN: - DAMAGED GRASPING MECHANISM - EXTERNAL DAMAGE OF ADJUSTING RING CAUSE OF FAULT: - QUICK COUPLER WORN OUT - DAMAGE CAUSED BY INCORRECT HANDLING DEVICE INTERACTION (2+ DEVICES) : WILL NOT HOLD/RETAIN, VISUAL : DEFORMED/BENT PER SERVICE REPORTS, THIS COMPLAINT WAS CONFIRMED. BASED ON THE INVESTIGATION FINDINGS, THE USER ERROR WAS IDENTIFIED AS THE ROOT CAUSE FOR THE DEVICE FAILURE DURING THE SERVICE EVALUATION. IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AND THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF J&J MEDTECH ORTHOPAEDICS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    THIS IS REPORT 2 OF 3 FOR (B)(4) IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE BARS INSIDE THE SCOPE OF THE HD EPSCP,1.9,30,60,CW_STORZ DEVICE WERE DAMAGED AND HAD POOR IMAGE QUALITY, THERE WAS NO LIGHT OUTPUT COMING THROUGH THE SCOPE OF THE 4K C-MNT SCP,4.0,30,167 DEVICE CAUSING BAD IMAGE QUALITY, AND THE COUPLER AC FFL 19 DEVICE WAS NOT HOLDING THE SCOPE CAUSING POOR IMAGE QUALITY. IT WAS NOT REPORTED IF SPARE DEVICES WERE AVAILABLE FOR USE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027491 COUPLER AC FFL 19 ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) FEM MEDOS INTERNATIONAL SàRL 10886705028610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown