BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 20225468 · Received September 16, 2024

    Report

    Report Number
    3005075853-2024-06920
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    June 27, 2023
    Report Date
    September 16, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001072
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/16/2024 D4: BATCH # A9C304 AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ATS45, WITH LOT/BATCH NUMBER A9C304, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. ADDITIONAL INFORMATION: THIS COMPLAINT WAS RECEIVED DIRECTLY FROM THE STATE OF SÃO PAULO HEALTH AUTHORITY (CVS) THROUGH AN ANONYMOUS REPORT, SO THE CUSTOMER IS UNKNOWN. THEREFORE, AT THE MOMENT NO FURTHER INFORMATION CAN BE OBTAINED BEYOND WHAT IS AVAILABLE IN THE COMPLAINT FILE. IF THE COMPLAINT IS RECEIVED FROM A DIFFERENT SOURCE AND THE ACCOUNT NAME INFORMATION IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 DURING AN UNKNOWN PROCEDURE, THE STAPLER CLOSED THE LOAD, BUT DID NOT PERFORM THE TRIP PROPERLY. IT STARTED STAPLING ONLY IN THE FIRST THREE STAPLES AND THEN STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353626 ETS FLEX ARTICNG LNR CUTR 45MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. A9C304 10705036001072

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown