BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD EPSCP,4.0,0,175,CW_STORZ

    MDR report key: 19084186 · Received April 10, 2024

    Report

    Report Number
    1221934-2024-01166
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    January 1, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HRX
    UDI-DI
    10886705028764
    PMA / PMN Number
    K080560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H10 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. UDI: (01)10886705028764(21)1213531 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, NEEDLE OUTER TUBE DENT(S), DISTAL TIP DISTAL TIP DAMAGED ¿ ILLUMINATION DISTAL TIP FIBER DAMAGED ¿ PARTICULATE, OPTICS PARTICULATE UNDER DISTAL LENS- PARTICULATE UNDER PROXIMAL LENS ¿ OPTICAL SYSTEM, OPTICAL COMPONENTS OPTICAL SYSTEM LOOSE PRISM LOOSE BROKEN LENSES IN OPTICAL SYSTEM ¿ COSMETIC ISSUE RUST/DISCOLORATION ¿ BROKEN (2+ PIECES) : DEVICE FRACTURED, VISUAL : DEFORMED/BENT, VISUAL : FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. THE DEVICE WAS NOT REPAIRABLE AND DISCARDED AS PER PROCEDURE. AS PART OF DEPUY MITEK¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE HD EPSCP,4.0,0,175,CW_STORZ SCOPE WAS NOT WORKING. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DURING IN-HOUSE ENGINEERING EVALUATION IT WAS DETERMINED THAT THE OPTICS OF THE SCOPE PARTICULATE UNDER THE DISTAL LENS, AND PARTICULATE UNDER THE PROXIMAL LENS. ALSO, THE LENS WAS BROKEN IN THE OPTICAL SYSTEM, A COSMETIC ISSUE WITH RUST/DISCOLORATION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340767 HD EPSCP,4.0,0,175,CW_STORZ ARTHROSCOPE HRX MEDOS INTERNATIONAL SARL 10886705028764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown