BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOD RELOAD

    MDR report key: 5476034 · Received March 3, 2016

    Report

    Report Number
    3005075853-2016-01260
    Event Type
    Malfunction
    Date Received
    March 3, 2016
    Date of Event
    January 20, 2016
    Report Date
    February 3, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. BATCH # M54Z6Z ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: I AM SEEKING ADDITIONAL FOLLOW IN REGARDS TO THE STAPLER NOT STAPLING WELL. WERE THERE ANY STAPLES MISSING FROM THE STAPLE LINE? WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES (B-FORMATION, IRREGULAR, LEGS STRAIGHT)? ON THE MEDIAL SIDE OF THE STOMACH THERE WASN¿T ANY STAPLES IN THE CARTRIDGE. THE ANALYSIS FOUND THAT ONE ECR60D CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS AND CARTRIDGE BODY WAS NOTED TO BE DAMAGED. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/3. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, THE SURGEON USED THE DEVICE. ON THE SECOND CARTRIDGE, HE USED THE GOLD RELOAD. ACCORDING TO THE SURGEON, AFTER THE USE ON THE TISSUE HE NOTICED THE TISSUE DIDN'T STAPLE WELL. HE HAND SEW THE TISSUE WITH PDS AND FINISHED THE SURGERY WITH THE SAME DEVICE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133222 GOD RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1