BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 3010310 · Received March 19, 2013

    Report

    Report Number
    3005075853-2013-01274
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 12, 2013
    Report Date
    February 19, 2013
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE ADDITIONAL INFORMATION: LUNG TISSUE. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? UNKNOWN. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 2ND. WHAT COLOR CARTRIDGE WAS BEING USED? UNKNOWN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? UNKNOWN. WAS BUTTRESSING MATERIAL UTILIZED? UNKNOWN. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WERE ANY UNEXPECTED NOISES HEARD? UNKNOWN. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNKNOWN. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? UNKNOWN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? UNKNOWN. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? THE PATIENT IS STILL IN THE HOSPITAL THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD PRESENT; IT WAS NOTED PARTIALLY FIRED. FURTHERMORE, THE CARTRIDGE METAL PAN WAS NOTED TO HAVE SCRATCHES ON THE BOTTOM. THE SCRATCHES WERE STRAIGHT AND RUNNING PARALLEL TO THE BOTTOM WITH RESPECT TO THE CARTRIDGE AND PARALLEL IN RESPECT TO THE DEVICE CHANNEL (METAL LOWER JAW COMPONENT THAT HOLDS THE CARTRIDGE IN PLACE). THE SCRATCHES ON THE CARTRIDGE METAL PAN AND THE INFORMATION PROVIDED IN THE EVENT DESCRIPTION ARE CONSISTENT WITH AN IMPROPER LOADING OF THE CARTRIDGE INTO THE DEVICE. WHEN THE CARTRIDGE IS NOT LOADED COMPLETELY THAT IS THE CARTRIDGE STOPS ARE NOT IN THE CARTRIDGE RELOAD ALIGNMENT SLOT, AT FIRING THE RELOAD WILL EJECT FORWARD AND SOME STAPLES WILL DEPLOY (FIRE OUT). PER INSTRUCTIONS FOR USE INSERT THE NEW RELOAD BY SLIDING IT AGAINST THE BOTTOM OF THE CARTRIDGE JAW UNTIL IT STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. A TEST RELOAD WAS LOADED INTO THE DEVICE USING THE STEPS ON THE INSTRUCTIONS FOR USE AND THE RELOAD WAS LOADED COMPLETELY WITHOUT ANY DIFFICULTY NOTED. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT, AND ALL THE STAPLES FORMED 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THOROSCOPY WITH LUNG BIOPSY PROCEDURE, THE DEVICE MISFIRED. THE DEVICE FIRED FINE ON THE FIRST FIRING. ON THE SECOND FIRING THE DEVICE CUT AND DID NOT STAPLE THEN THE RELOAD FELL OUT OF THE DEVICE INTO THE PATIENT. THE PATIENT STARTED BLEEDING AND WAS CONVERTED TO OPEN. THE RELOAD WAS RETRIEVED. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. THE PATIENT IS STILL IN CVSU INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114321 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4CM3H

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention