BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM

    MDR report key: 1883718 · Received October 27, 2010

    Report

    Report Number
    3005075853-2010-06106
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED IN GOOD CONDITIONS AND WITH A CARTRIDGE RELOAD. THE CARTRIDGE WAS RETURNED PARTIALLY FIRED AND WAS NOTED TO HAVE A WEDGE BAND BYPASS AS THE LEFT SIDE WAS FULLY FIRED AND THE RIGHT SIDE WAS PARTIALLY FIRED 1/2. THE CARTRIDGE LOCK OUT WAS FOUND NORMAL. IN ADDITION THE CARTRIDGE DECK AND SLED WERE FOUND DAMAGED. THE DAMAGE FOUND ON THE CARTRIDGE DECK IS CONSISTENT WITH DAMAGE CAUSED WHEN THE DEVICE IS CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED GETS DAMAGED. WHEN THE MECHANISM IS FORCED THE WEDGE BAND CAN BYPASS THE SLED. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INSTRUCTIONS. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE, THE DEVICE WAS FIRED AND ONLY STAPLED ON THE LIVER SIDE NO STAPLES PRESENT ON THE ARTERY SIDE. SUTURES WERE USED TO COMPLETE THE PROCEDURE. THE PATIENT BLED AND HAD TO BE TRANSFUSED AND WAS IN AN EXTREMELY POOR STATE POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR CUTTER (VASCULAR/THIN) - 35 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4RM4J

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention