BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR 45MM

    MDR report key: 1156148 · Received September 9, 2008

    Report

    Report Number
    3005075853-2008-01593
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 9/9/2008. EVALUATION SUMMARY: TWO DEVICES (A-B) WERE RETURNED FOR ANALYSIS. DEVICE A WAS RETURNED WITH THE FIRING MECHANISM DAMAGED. TWO RELOADS WERE ALSO RETURNED PARTIALLY FIRED. ONE RELOAD WAS NOTED TO HAVE A WEDGE BAND BYPASS, AS THE RIGHT SIDE WAS 3/4 FIRED AND THE LEFT SIDE WAS 1/3 FIRED. IN ADDITION, THE CARTRIDGE DECK WAS DAMAGED. DAMAGE TO THE CARTRIDGE DECK CAN OCCUR IF THE DEVICE IS CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED, NOT LEAVING SUFFICIENT SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, RESULTING IN DAMAGE TO THE SLED. WHEN THE MECHANISM IS FORCED THE WEDGE BAND WILL BYPASS THE SLED. DEVICE B WAS RETURNED WITH THE FIRING MECHANISM DAMAGED AND NO RELOAD PRESENT. NO FUNCTIONAL TESTS COULD BE PERFORMED ON EITHER DEVICE DUE TO DAMAGE OF THE INTERNAL COMPONENTS. A 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE RELEASE CRITERIA. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A VIDEO ASSISTED THORACOTOMY PROCEDURE, WHEN FIRING IT MADE A LOUD AUDIBLE POPPING NOISE AND THE DEVICE WOULD NOT OPEN AND LOCKED ON TISSUE. THEY MANUALLY OPENED THE DEVICE WITH AN INCOMPLETE STAPLE LINE. ATTEMPTED TO REPEAT THE SAME PROCESS WITH NEW DEVICE WITH THE SAME OUTCOME. OPENED A DIFFERENT PRODUCT CODE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR CUTR 45MM GDW ETHICON ENDO-SURGERY, LLC. NA E4LE1Y

    Patients

    Seq Age Sex Outcome Treatment
    1