BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS - ENDOSCOPIC LINEAR

    MDR report key: 2181588 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-02987
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    May 27, 2011
    Report Date
    July 18, 2011
    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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY PART OF THE STAPLE LINE FIRED, THE RIGHT SIDE OF THE RELOAD DID NOT DISCHARGE. THE PATIENT REQUIRED A BLOOD TRANSFUSION BECAUSE THE STAPLERS DID NOT FORM COMPLETELY ON THE RIGHT SIDE OF THE RELOAD. THE PATIENT REQUIRED 4 UNITS OF BLOOD. THE ORIGINAL INCISION FOR THE SURGERY HAD TO BE EXTENDED 4 TO 5 INCHES SO DR. (B)(6) COULD VISUALIZE THE VEIN TO PLACE A VASCULAR CLAMP TO STOP THE BLEEDING. THE PROCEDURE CONTINUED ONCE THE BLEEDING WAS UNDER CONTROL, THE CASE WAS EXTENDED (B)(6). THE CONDITION OF THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PATIENT DID HAVE DIABETES BUT WAS CONSIDERED A GOOD PATIENT FOR THE PROCEDURE. THE PATIENT HAD NOT RECEIVED CHEMO OR RADIATION TREATMENT PRIOR TO SURGERY.

    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 PARTIALLY FIRED. THE CARTRIDGE LOCKOUT WAS FOUND NORMAL. IN ADDITION THE CARTRIDGE DECK WAS 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). A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN RT VA THORACOTOMY PROCEDURE, AFTER FIRING THE DEVICE, IT WAS FOUND THAT THE STAPLES ONLY PARTIALLY FIRED, BUT THE DEVICE FULLY CUT. AS A RESULT OF THIS, THE PROCEDURE WAS EXTENDED BY ONE HOUR; THE PROCEDURE WAS CHANGED; THE INCISION WAS EXTENDED AND THE PATIENT REQUIRED A BLOOD TRANSFUSION. THE CASE WAS COMPLETED WITH A SAME/LIKE DEVICE. THE CASE CONTINUED WITH A GOOD OUTCOME. IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. ADDITIONAL FOLLOWUP HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS - ENDOSCOPIC LINEAR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43A09

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention