BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 2211406 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03293
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    July 21, 2011
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). WEDGE BAND BYPASS. THE ANALYSIS RESULTS FOUND THAT THE ATW35 DEVICE WAS RETURNED IN GOOD CONDITIONS, A 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 1/3. THE CARTRIDGE LOCKOUT WAS FOUND NORMAL. IN ADDITION THE CARTRIDGE DECK AND SLED WERE FOUND DAMAGED. THE DAMAGED FOUND ON THE CARTRIDGE DECK IS CONSISTENT WITH DAMAGED 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% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4) .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP APPENDECTOMY PROCEDURE, THERE WAS AN INCOMPLETE STAPLE LINE. NO FURTHER INFORMATION IS AVAILABLE. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1