BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 2173382 · Received July 23, 2011

    Report

    Report Number
    3005075853-2011-02962
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    May 20, 2011
    Report Date
    May 24, 2011
    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
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT A: DAMAGED CARTRIDGE LOCKOUT TAB. INSTRUMENT B: DAMAGED ARTICULATION BANDS. THE ANALYSIS SHOWED THAT THE ATB35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED AND WITH THE RELOAD LOCKOUT 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. 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 NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE ANALYSIS SHOWED THAT THE ATB35 DEVICE WAS RECEIVED WITH THE ARTICULATION MECHANISM DAMAGED AND WITHOUT A RELOAD PRESENT. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD ON THE LEFT SIDE AND IT FIRED AS INTENDED. HOWEVER, ON THE CENTER AND RIGHT SIDE THE DEVICE COULD NOT BE TESTED AS THE ARTICULATION MECHANISM WAS DAMAGED. THE DEVICE WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS; THE LEFT ARTICULATION BAND WAS FOUND DAMAGED. ALTHOUGH NO CONCLUSION COULD BE REACH ON WHAT CAUSED THE DAMAGE TO THE BAND, IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS; (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HIATUS HERNIA AND LAPAROSCOPIC NISSEN PROCEDURE, IT IS ALLEGED THAT THE SURGEON OPENED A SECOND DEVICE. THE SURGEON INSISTED THAT THE SCRUB NURSE DRY FIRED THE INSTRUMENT FIRST. THE STAPLER FIRED WITH NO PROBLEMS. THE SURGEON THEN RELOADED THE INSTRUMENT WITH A BLUE RELOAD. WHEN USING THE STAPLER ON THE PATIENT THE STAPLER LOCKED OUT. ON EXAMINING THE RELOAD, IT APPEARS TO HAVE PARTIALLY FIRED. THE SURGEON THEN CHANGED TO A COMPETITOR PRODUCT TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK E4ML8P

    Patients

    Seq Age Sex Outcome Treatment
    1