BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 2183126 · Received July 28, 2011

    Report

    Report Number
    3005075853-2011-03086
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 28, 2011
    Report Date
    July 8, 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
    CA
    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 TSW35 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 1/2 FIRED. 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; (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 BY THE REP THAT DURING A VATS LOBECTOMY PROCEDURE, THE DEVICE WAS FIRED AND STAPLES ON ONE SIDE OF THE RELOAD DID NOT FORM CORRECTLY, RESULTING IN A FAILED STAPLE LINE. THE SURGEON EXAMINED THE RELOAD AND COULD SEE NO DRIVERS VISIBLE ALONG ONE SIDE. HEMOSTASIS WAS NOT ACHIEVED ON THE SPECIMEN SIDE OF THE PULMONARY VEIN. IT WAS OCCLUDED WITH A SPONGE FORCEPS AND OVERSEWN TO ACHIEVE HEMOSTASIS. THE PROCEDURE WAS EXTENDED BY 20 MINUTES. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. ADDITIONAL FOLLOWUP: THE PATIENT DID NOT REQUIRE A BLOOD TRANSFUSION. THE CONCERN WITH THE STAPLE LINE WAS ON THE SPECIMEN SIDE OF THE STAPLE LINE, AND THE LOBE WAS IN THE PROCESS OF BEING REMOVED. ANY BLOOD LOSS WAS DUE TO BACK BLEEDING FROM THE LOBE THAT WAS BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43N4H

    Patients

    Seq Age Sex Outcome Treatment
    1