BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 4131264 · Received October 1, 2014

    Report

    Report Number
    3005075853-2014-06767
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 12, 2014
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED WITH THE FIRING MECHANISM DAMAGED AND WITH TR45W CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10 AND WITH THE LOCKOUT SPRING NORMAL. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE; HOWEVER, THE DEVICE CLOSED AND OPENED PROPERLY DURING TESTING. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND THE FIRING TRIGGER TEETH AND THE FIRING TRIGGER POST WERE FOUND BROKEN. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT CAUSED THE FIRING MECHANISM TO FAIL, IT IS POSSIBLE THAT THE DEVICE WAS FIRED ON TISSUE THICKER THAN INDICATED OR THROUGH A LOCKED CARTRIDGE IN PREVIOUS FIRINGS. WHEN EITHER OR BOTH OF THESE SCENARIOS OCCUR THE COMPONENTS IN THE FIRING MECHANISM CAN BE DAMAGED. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. 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). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY PROCEDURE, THE STAPLER JAMMED WITH A WHITE RELOAD IN THE GUN AND WAS UNABLE TO OPEN ON THE RENAL ARTERY. THE STAPLER HAD ALREADY BEEN FIRED "THREE OR FOUR TIMES" PRIOR TO JAMMING AND THESE FIRINGS WENT WITHOUT ISSUE. ON THE FIRING THAT RESULTED IN THE JAM, THE DEVICE WAS FULLY ARTICULATED AND THE SURGEON STATED THAT THE DEVICE WAS HARD TO CLOSE. IN ADDITION, HE STATED THAT WHEN HE PULLED THE FIRING HANDLE HE FELT AND HEARD A "POP." HE ATTEMPTED MULTIPLE TIMES TO OPEN THE DEVICE WITH THE REAR BUTTON WAS ULTIMATELY UNABLE TO DO SO. THE CASE WAS COMPLETED BY PLACING HEMOCLIPS ON THE PATIENT SIDE OF THE VESSEL AND CUTTING THE RENAL ARTERY BETWEEN THE CLIPS AND THE STAPLER TO FREE THE DEVICE. THE PATIENT DID RECEIVE A UNIT OF BLOOD BUT ACCORDING TO THE SURGEON, HE STATED THAT THIS WAS NOT DO TO THE STAPLER MALFUNCTION IN HIS OPINION. HE FELT IT WAS DUE TO ISSUES ARISING FROM THE CRYOTHERAPY APPLIED TO THE KIDNEY PRIOR TO THE STAPLER BEING FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611348 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EY8K

    Patients

    Seq Age Sex Outcome Treatment
    1