BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GREEN RELOAD FOR ECHELON 60

    MDR report key: 18930127 · Received March 19, 2024

    Report

    Report Number
    3005075853-2024-02249
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    January 1, 2024
    Report Date
    March 19, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001782
    PMA / PMN Number
    K051002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/19/2024. D4: BATCH # UNK. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: HOW WAS THE PRODUCT PURCHASED? BETWEEN THE FEDERAL STATE BUDGETARY INSTITUTION "GNTSK IM. A.N. RYZHIKH" MR AND THE DISTRIBUTOR LLC "(B)(4)" IN ACCORDANCE WITH THE FEDERAL LAW OF APRIL 05, 2013 "44-FZ" ON THE CONTRACT SYSTEM IN THE FIELD OF PROCUREMENT OF GOODS, WORKS, SERVICES TO MEET STATE AND MUNICIPAL NEEDS "BASED ON THE RESULTS OF THE ELECTRONIC AUCTION ANNOUNCED BY NOTICE DATED SEPTEMBER 26, 2023, ON THE BASIS OF THE PROTOCOL FOR SUMMING UP THE RESULTS OF DETERMINING THE SUPPLIER, A CONTRACT WAS CONCLUDED FOR THE SUPPLY OF CARTRIDGES WITH STAPLES FOR ECHELON FLEX PLUS STAPLING AND CUTTING DEVICES. ¿ IS THERE AN INDICATION OF HOW THE PRODUCT WAS DISTRIBUTED? SEE ABOVE ¿ IS THERE ANY INDICATION OF THE SOURCE? ¿ BASED ON THE PACKAGING, IS THERE ANY INDICATION OF WHICH MARKET THE ORIGINAL GENUINE PRODUCT MAY HAVE COME FROM? THE PRODUCT PACKAGING CONTAINS MARKINGS INDICATING THAT IT IS IMPORTED FOR TURKEY AND FOR USE IN TURKEY. THE MARKING DOES NOT COMPLY WITH THE REQUIREMENTS OF RUSSIAN LEGISLATION. THE PACKAGING AND LABELING DATA DO NOT CORRESPOND TO THE INFORMATION FROM THE REGISTER OF MEDICAL DEVICES AND ORGANIZATIONS (INDIVIDUAL ENTREPRENEURS) ENGAGED IN THE PRODUCTION AND MANUFACTURE OF MEDICAL DEVICES. THE PLACE OF MANUFACTURE OF THE MEDICAL DEVICE IS NOT INDICATED IN ACCORDANCE WITH THE REGISTRATION CERTIFICATE ¿ WAS THE DEVICE USED ON A PATIENT? IF SO, WAS THERE ANY PATIENT CONSEQUENCE? ¿ IS A PHOTO AVAILABLE OF THE PRODUCT? SEE ATTACHMENT '(B)(6) (B)(6) 2024' ¿ IS THE DEVICE AVAILABLE TO BE RETURNED FOR EVALUATION? IF SO, PLEASE PROVIDE THE STATUS OF THE RETURN SAMPLE AND ANY AVAILABLE TRACKING INFORMATION. AS PART OF THE WORK WITH COMPLAINTS ABOUT PARALLEL IMPORTS, WE DO NOT REQUEST A LETTER OF COMPLAINT AND THE DEVICE FOR EXPERTISE. IT IS NECESSARY TO CHECK THE SHIPPING CHAINS AND ANALYZE THE DATA IN THE PHOTO WITH THE DATA FROM THE BATCH RECORDS FOR COMPLIANCE. INVESTIGATION SUMMARY: THIS IS AN ANALYSIS OF THE PHOTOS SUBMITTED TO ETHICON ENDO-SURGERY FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW BOXES WITH A LABEL WITH THE PRODUCT CODE ECR60G, LOT # 347A42, EXP. DATE: 2026-05-31. A LOT TRACE WAS PERFORMED ON THE LOT PROVIDED AND IT WAS CONCLUDED THAT THE FILE WAS CONFIRMED AS A DIVERSION. ADDITIONALLY, THE ARTWORK PRINT ON THE TYVEK WAS REVIEWED AND COMPARED WITH AUTHENTIC PACKAGE ARTWORK AND DID NOT MATCH THE ARTWORK PRINT DUE TO SEVERAL INCONSISTENCIES NOTED ON THE PRINTED AND DOES NOT COMPLY WITH J&J STANDARDS. BASED ON THE PHOTOS REVIEWED, THE SUSPECT DIVERSION AND THE COUNTERFEIT PRODUCT ARE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 347A42, AND NO NON-CONFORMANCES WERE IDENTIFIED THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRODUCT WAS SUSPECTED COUNTERFEIT. FURTHER INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564573 GREEN RELOAD FOR ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 347A42 10705036001782

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown