BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K C-MNT SCP,4.0,0,167,MITEK

    MDR report key: 19379650 · Received May 23, 2024

    Report

    Report Number
    1221934-2024-01687
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    March 7, 2024
    Report Date
    May 23, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL
    Product Code
    HRX
    UDI-DI
    10886705032068
    PMA / PMN Number
    K981751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. H11 ADDITIONAL NARRATIVE: D10: CONCOMITANT MED PRODUCTS AND THERAPY DATES: HD EPSCP,4.0,30,167,MITEK DEVICE, 378/2024 E3: REPORTER IS A J&J SALES REPRESENTATIVE. UDI: (B)(4). THE INVESTIGATION HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION: 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) OUTER TUBE BENT - OUTER TUBE DAMAGED, DISTAL TIP DISTAL TIP DAMAGED DEEP NICKS/DINGS/SCRATCHES - ILLUMINATION DISTAL TIP FIBER DAMAGED - OPTICAL SYSTEM, OPTICAL COMPONENTS DISTAL COVER GLASS/NEGATIVE DAMAGED SCRATCHED/RESIDUE PROXIMAL COVER GLASS DAMAGED RESIDUE ¿ BROKEN (2+ PIECES) : DEVICE FRACTURED ¿ VISUAL : DEFORMED/BENT ¿ LABELING : ILLEGIBLE ETCH PER SERVICE REPORTS, THIS COMPLAINT CAN BE CONFIRMED. THE DEFECTIVE PARTS NEEDS TO BE REPLACED TO RESOLVE THE ISSUES. THE FAULTY PART 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT DURING PRE SURGERY FOR AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS DETERMINED THAT THE 4K C-MOUNT ENDOSCOPE, MITEK LOCK 0 DEGREE X 4 MM X 167 MM DEVICE AND THE HD EPSCP,4.0,30,167,MITEK DEVICE SCOPES WERE CRACKED. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICES WERE FRACTURED. THERE WAS NO PROCEDURE INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749613 4K C-MNT SCP,4.0,0,167,MITEK ARTHROSCOPE HRX MEDOS INTERNATIONAL SàRL 10886705032068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown