BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 3172581 · Received June 17, 2013

    Report

    Report Number
    3005075853-2013-03040
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ECHELON 60 TO FIX THE ISSUE RELATED TO THE 45, BUT THE ECHELON LOCKED OUT? FIRE #1: ATS45 WAS LOADED WITH THE 6R45M, BUT THE TECH LEFT THE RETAINING COVER ON AND AFTER THE ATTEMPT TO FIRE, THE CARTRIDGE FEEL OUT OF THE STAPLER IN THE BELLY. FIRE #2: EC60A WAS LOADED BUT WITH AN ETS45 CARTRIDGE. THIS ECHELON LOCKED OUT AFTER ATTEMPTING TO FIRE. FIRE #3: EC60A UNKNOWN WHY AN ADDITIONAL INSTRUMENT WAS OPENED. FIRE #4: ATS45 SURGEON WAS NOT CERTAIN WHICH INSTRUMENT SUCCESSFULLY STAPLED THE APPENDIX, BUT SUSPECTS IT WAS THIS LAST FIRE APPROPRIATELY LOADED WITH THE 6R45B. ON WHICH FIRING DID THE EVENT OCCUR? FIRST FIRINGS. WHAT COLOR CARTRIDGE WAS BEING USED? DETAILED BELOW. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? WOULDN¿T FIRE. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? UNKNOWN. WHAT WAS THE APPEARANCE OF THE STAPLES (IRREGULAR SHAPES, LEGS STRAIGHT)? UNKNOWN. WAS THE DEVICE FIRED OVER AN EXISTING STAPLE LINE OR CLIP? UNKNOWN. WAS BUTTRESSING MATERIAL USED? IF YES, WHAT KIND? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. AS A LOT NUMBER WAS NOT RECEIVED, A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON WAS USING THE DEVICE ACROSS THE MESO-APPENDIX WHEN STAPLES WERE NOT FORMED PROPERLY. CASE COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273890 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1