BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 1860011 · Received October 7, 2010

    Report

    Report Number
    3005075853-2010-05766
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 14, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED FIRING TRIGGER RETURN SPRING POST. THE ANALYSIS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH A WHITE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED PARTIALLY FIRED 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. 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 BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THE DEVICE WAS FIRED BY THE FELLOW FOR THE SECOND TIME ACROSS THE VEIN AND THE DEVICE CUT, HOWEVER, DID NOT STAPLE. TWO STAPLES DEPLOYED ON THE PROXIMAL END OF THE RELOAD AND THEY WERE NOT FORMED. NONE OF THE OTHER STAPLES DEPLOYED. A DIFFERENT DEVICE OF ANOTHER PRODUCT CODE WAS USED TO REPAIR THE STAPLE LINE AND TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TD7V

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-(B)(4)