BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO LINEAR CUTTERS

    MDR report key: 6026486 · Received October 13, 2016

    Report

    Report Number
    3005075853-2016-05881
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 2, 2016
    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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # N5571V. ADDITIONAL INFORMATION: THE DEVICE WAS BEING USED FOR THE FIRST FIRING ON THE STOMACH WITH A BLUE RELOAD. IT TOOK TWO HANDS TO BE ABLE TO CLOSE THE DEVICE ON TISSUE. THE DEVICE WAS ATTEMPTED TO BE FIRED, BUT WOULD NOT FIRE. WHEN IT WAS RELEASED FROM THE TISSUE, THERE WERE ONLY A FEW STAPLES DEPLOYED AND NO CUT LINE. THE DEVICE WAS REMOVED, SOME ADDITIONAL DISSECTION WAS PERFORMED AND A SECOND DEVICE WAS USED TO FIRE ACROSS A BETTER LOCATION ON THE STOMACH. THE SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUES. THE SALES REP WAS PRESENT FOR THE CASE. THE ANALYSIS SHOWED THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A 6R45B CARTRIDGE LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 1/10 AND WITH THE RELOAD LOCK OUT SPRING DAMAGED. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN THE FIRING CYCLE IS STARTED, INTERRUPTED, RELEASED, AND RESTARTED. WHEN FIRING THE DEVICE MAKE SURE THAT THE FIRING STROKE IS COMPLETED. DO NOT PARTIALLY FIRE THE DEVICE. FIRE THE DEVICE BY SQUEEZING THE FIRING TRIGGER COMPLETELY UNTIL IT RESTS ON THE CLOSING TRIGGER. ONCE THE FIRING CYCLE HAS BEEN INITIATED, IT MUST BE COMPLETED. IF RE-INITIATION OF FIRING IS RESUMED, THE DEVICE WILL LOCKOUT. FIRING THROUGH THE LOCKOUT MECHANISM WILL BREAK THE DEVICE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR MORE INFORMATION. IF A RELOAD IS NOT LOADED, OR IS IMPROPERLY LOADED IN THE RELOAD JAW, THE ANVIL JAW WILL NOT CLOSE. IF HIGH RESISTANCE IS FELT WHEN SQUEEZING THE CLOSING TRIGGER, CHECK TO ENSURE THAT THE RELOAD IS PRESENT AND THE RELOAD ALIGNMENT TAB IS SEATED IN THE RELOAD ALIGNMENT NOTCH. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC BAND REMOVAL PROCEDURE, THE DEVICE CLOSED BUT DIDN'T STAPLE PROPERLY. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677959 ENDO LINEAR CUTTERS STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA N4LP1R

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - 6R45B