BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO ILS 21MM, CURVED

    MDR report key: 3160040 · Received June 10, 2013

    Report

    Report Number
    3005075853-2013-02912
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC VERTICAL GASTROPLASTY PROCEDURE, THE SURGEON PLACED THE DEVICE ON THE STOMACH. BEFORE FIRING THE SURGEON DID MANIPULATIONS ON THE TISSUE OF THE STOMACH FOR A FEW MOMENTS UNTIL DECIDING ON THE POSITION OF THE FIRING IN THE MIDDLE OF THE STOMACH, FEW CM FROM THE LESSER CURVATURE. THE SURGEON CLOSED THE DEVICE AND FIRED. HE OPENED THE DEVICE AND DISCOVERED THERE WERE NO STAPLES. THE SURGEON REPLACED THE INSTRUMENT, AND CONTINUED THE OPERATION WITH CDH25- THE FIRING WAS SUCCESSFUL AND THE STAPLE LINE WAS GOOD. IN A QUESTIONING CONVERSATION WITH THE SURGEON HE SAID THAT HE DIDN¿T FEEL ANYTHING UNUSUAL IN THE DEVICE BEFORE AND DURING THE FIRING, THERE WASN¿T UNUSUAL SOUND AND THERE WASN¿T NEED TO OPERATE UNUSUAL FORCE ON THE DEVICE. THERE WAS NO DAMAGE TO THE TISSUE OR TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260557 ENDO ILS 21MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H44M59

    Patients

    Seq Age Sex Outcome Treatment
    1