BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    75 MM NTLC SELECTABLE RELOAD

    MDR report key: 15302908 · Received August 26, 2022

    Report

    Report Number
    3005075853-2022-05585
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    January 1, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002833
    PMA / PMN Number
    K092577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ONLY EVENT YEAR KNOWN: 2022. BATCH # 522A73. THIS IS AN ANALYSIS OF TWO PHOTOS SUBMITTED ALONG WITH DEVICE ANALYSIS. THIS IS AN ANALYSIS OF THE TWO PHOTOS SUBMITTED FOR EVALUATION. DURING THE VISUAL ANALYSIS, THE FOLLOWING WAS OBSERVED: THE PHOTOS SHOW A BLACK RELOAD FROM BATCH AREA: 522A73. ALSO, SOME DRIVERS CAN BE SEEN UP (2/3), AND AFTER THAT, SOME PROTRUDING STAPLE LEGS WERE NOTED. DEVICE INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED RELOAD. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT THE SR75 RELOAD WAS RECEIVED WITH NO APPARENT DAMAGED. THE RELOAD HAD THE PROXIMAL 53 DRIVERS UP AND THE REMAINING DRIVERS DOWN WITH STAPLES PRESENT AND A SWING TAB IN THE LOCKED POSITION. THE RELOAD SWING TAB WAS RESET IN ORDER TO FIRE THE CARTRIDGE. THE RETURNED RELOAD WAS TESTED WITH A TEST DEVICE AND FIRED WITHOUT ANY DIFFICULTIES. THE STAPLE LINE WAS COMPLETE, AND THE STAPLES MEET THE STAPLE FORM RELEASE CRITERIA. THE EVENT REPORTED WAS CONFIRMED AND IT IS RELATED TO IMPROPER USE OF THE DEVICE. IT SHOULD BE NOTED THAT THE RELOAD IS DESIGNED TO LOCKOUT, AS A SAFETY FEATURE, IF ANY STAPLES HAVE BEEN FIRED FROM THE CARTRIDGE RELOAD. IN ADDITION, FAILURE TO COMPLETE THE STROKE MAY RESULT IN AN INCOMPLETE STAPLE LINE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. AS PART OF ETHICON ENDO SURGERY¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A RIGHT HEMICOLECTOMY THE DOCTOR COULD NOT COMPLETELY FIRE THE NTLC. THE FIRST FIRING WENT SMOOTH, AND THE SECOND FIRING WAS UNABLE TO TRANSECT THE ENTIRE COLON. THE SURGERY WAS COMPLETED WITH SUTURE AND SCALPEL TO REMOVE TRANSECT THE REMAINING COLON. NO PARTS WERE LEFT INSIDE THE PATIENT'S BODY CAVITY. THERE WAS NO DELAY TO THE SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616303 75 MM NTLC SELECTABLE RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. SR75 540A17 10705036002833

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown