BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 1930129 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07190
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    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). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED AS INTENDED, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED WITHOUT ANY DIFFICULTIES AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. THE EVENT DESCRIPTION AND NOTES INDICATES THE POTENTIAL FOR AN IMPROPERLY INSTALLED CARTRIDGE; EITHER THE CARTRIDGE IS NOT FULLY INSERTED INTO THE CHANNEL OR IT IS "LONG LOADED". IF "LONG LOADED" THE CARTRIDGE EXTENDS BEYOND THE CARTRIDGE JAWS FURTHER THAN IT SHOULD (HOLDING FEATURES OF THE CARTRIDGE ARE NOT SNAPPED INTO THE CHANNEL SLOTS AND THE HOLDING FEATURES ARE IN FRONT OF THE CHANNEL). IF THE CARTRIDGE IS NOT PROPERLY SNAPPED INTO THE CHANNEL OR IS "LONG LOADED" THE CARTRIDGE CAN MOVE FORWARD DURING THE FIRING STROKE AND SOME STAPLES MAY BE DEPLOYED, THE DEVICE WILL CONTINUE TO CUT, AND THE CARTRIDGE MAY BE PUSHED OUT. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY. THE SURGEON WENT TO FIRE ACROSS THE IP LIGAMENT AND THE CARTRIDGE SHOT OUT OF THE JAWS AND INTO THE PELVIS. THE DEVICE WAS RELEASED FROM THE TISSUE AND ANOTHER DEVICE WAS USED TO COME BACK ACROSS THE SAME AREA AND STAPLED TO COMPLETE THE CASE. SOME OOZING AT THE IP LIGAMENT, BUT THE OTHER DEVICE WAS USED TO FIRE ACROSS AND STOP THE OOZING. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK G4TN38

    Patients

    Seq Age Sex Outcome Treatment
    1