BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG

    MDR report key: 2061417 · Received April 18, 2011

    Report

    Report Number
    3005075853-2011-01540
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B: BATCH #: F5UV0L, EXP DATE: 03/23/2014; MFR DATE: 04/23/2009. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH THREE RELOADS PRESENT. THE RETURNED RELOADS WERE PARTIALLY FIRED WHICH INDICATES THAT THE DEVICE'S FIRING CYCLE WAS INTERRUPTED. 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. EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING TESTING. THE ANALYSIS RESULTS FOUND THAT THE ATS45 DEVICE (B) 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 WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE CARTRIDGE WAS LOADED INTO THE DEVICE WITHOUT DIFFICULTIES AND DID NOT FALL OUT DURING THE VISUAL AND FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE FIRST DEVICE, THE STAPLES WERE LOOSE AND DID NOT STAPLE ALL THE WAY ACROSS. THE SECOND DEVICE, THE RELOAD FELL OFF INSIDE THE PATIENT. THE SURGEON HAD TO RETRIEVE IT. THE TWO WHITE CARTRIDGES AND ONE RELOAD MISFIRED. THEY COMPLETED THE CASE WITH ANOTHER DEVICE. THE SURGERY WAS DELAYED BY TEN MINUTES WHILE THE DEVICE WAS RETRIEVED FROM ANOTHER BUILDING. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL FOLLOW-UP: DEVICE DID NOT CUT THE TISSUE AT ALL. SOME STAPLES DEPLOYED SOME WERE STRAIGHT, THE OTHERS WERE FORMED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK F4NL8F

    Patients

    Seq Age Sex Outcome Treatment
    1 TR45W, 6R45B