BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS 29MM, CURVED

    MDR report key: 9642543 · Received January 29, 2020

    Report

    Report Number
    3005075853-2020-00586
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    January 6, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036003502
    PMA / PMN Number
    K940967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH #UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGERY? WHAT HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS HIS/HER EXPERIENCE WITH THE DEVICE? SA WITH LOTS OF EXPERIENCE WHERE IN THE GREEN GAP SETTING SCALE WAS THE INDICATOR LOCATED PRIOR TO FIRING (LOW-B, MIDDLE-B, OR HIGH-B)? DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND THEN RETIGHTEN PRIOR TO FIRING? WAS THE DEVICE DIFFICULT TO CLOSE? WAS THE DEVICE DIFFICULT TO FIRE? IT WAS DIFFICULT TO FIRE. WERE THE DONUTS INSPECTED? IF SO, PLEASE DESCRIBE. WAS A COMPLETE TRANSECTION OF THE CUTTING WASHER VISUALLY CONFIRMED? WASHER DID NOT APPEAR TO BE COMPLETELY BROKEN. WERE THERE ANY STAPLE FORMATION ISSUES IDENTIFIED? WAS A LEAK TEST PERFORMED? IF SO, WHAT WAS THE RESULT? THERE WAS A LEAK. HOW WAS THE LEAK ADDRESSED? THE ANASTOMOSES WAS OVERSEWN. WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION AT ANY POINT THROUGHOUT THE CARE OF THE PATIENT? WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? DNK. WHAT IS THE CURRENT STATUS OF THE PATIENT? DNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMOID COLECTOMY, THE SURGEON WENT TO FIRE THE DEVICE AND DID NOT HEAR THE CRACK. THERE WAS A LEAK. PATIENT CONSEQUENCES ARE UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108613 ENDO ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. ECS29A T94R5U 10705036003502

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female