BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 4 MM X 167 MM

    MDR report key: 17063954 · Received June 5, 2023

    Report

    Report Number
    1221934-2023-02272
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 6, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705032075
    PMA / PMN Number
    K080560; K98
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    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 DEPUY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY 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: UDI: (B)(4). E3: REPORTER IS A J&J SALES REPRESENTATIVE. H4: THE DEVICE MANUFACTURE DATE IS CURRENTLY UNAVAILABLE. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE WAS RECEIVED AT THE MANUFACTURING SITE AND EVALUATED. DURING THE SERVICE EVALUATION THE FOLLOWING DEFECTS WERE IDENTIFIED: OUTER TUBE DAMAGED. DISTAL TIP DAMAGED, DISTAL TIP FIBER DAMAGED. OPTICAL SYSTEM, OPTICAL COMPONENTS - DISTAL COVER GLASS/NEGATIVE DAMAGED. BROKEN (2+ PIECES): DEVICE FRACTURED OPTICAL. FUNCTIONAL: DAMAGED CONNECTOR TUBE. MINOR SCRATCHES ON THE UNIT. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. THE DEFECTIVE PARTS NEEDS TO BE REPLACED TO RESOLVE THE ISSUES. THE FAULTY PARTS WAS IDENTIFIED AS THE ROOT CAUSE FOR THE DEVICE FAILURE DURING THE SERVICE EVALUATION. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. 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 REVIEW: MANUFACTURING RECORD EVALUATION IS NOT REQUIRED AS THE REPORTED EVENT IS NOT ASSOCIATED WITH THE MANUFACTURING PROCESS AND/OR THE POTENTIAL CAUSE OF THE DEFECT CANNOT BE ASSOCIATED TO MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ADAPTERS ON THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 4 MM X 167 MM DEVICE WOULD NOT COME APART FROM ONE ANOTHER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS BROKEN/FRACTURED. 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
    1094766 4K C-MOUNT ENDOSCOPE, MITEK LOCK 30 DEGREE X 4 MM X 167 MM RIGID ARTHROSCOPE, REUSABLE HRX MEDOS INTERNATIONAL SARL 242268 10886705032075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown