BEUDAMED
    FDA Adverse Event Death Summary report: N

    GST GREEN RELOAD, 60MM, 6 ROW

    MDR report key: 10025415 · Received May 5, 2020

    Report

    Report Number
    3005075853-2020-02492
    Event Type
    Death
    Date Received
    May 5, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 17, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014713
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT: 7/15/2020. B2; H1,6: CORRECTED DATA. ADDITIONAL INFORMATION RECEIVED: THE PATIENT DIED DUE TO FISTULA AND OTHER COMPLICATIONS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. HOW LONG AFTER INITIAL PROCEDURE DID PATIENT EXPIRE? PLEASE PROVIDE TIMELINE OF EVENTS. DID THE PATIENT RECEIVE ANY MEDICAL INTERVENTION AFTER INITIAL PROCEDURE (REOPERATION)? IF SO, PLEASE PROVIDE DETAILS OF WHAT WAS FOUND DURING REOPERATION. HOW WAS THE LEAK IDENTIFIED? WAS THE LOCATION OF THE LEAK ON THE STAPLE LINE WHERE ISSUES WERE EXPERIENCED DURING INITIAL PROCEDURE? WHAT STAPLER WAS USED WITH THE REPORTED RELOAD? WHAT OTHER COLOR RELOADS WERE USED? DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? WAS BUTTRESSING MATERIAL USED? WHAT WAS THE PATIENT BMI? WAS AN AUTOPSY PERFORMED? IF SO, CAN THE RESULTS BE SHARED? DOES THE SURGEON BELIEVE THE EVENT WAS RELATED TO ISSUE EXPERIENCED IN INITIAL PROCEDURE?

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY, THE SURGEON STARTED STAPLING WITH THE GREEN LOAD FOR THE SECOND FIRE, BUT REALIZED IT WAS BLEEDING WHEN HE FINISHED. HE VERIFIED THAT THERE WAS ONLY A CUT LINE AND THE STAPLE LINE WAS OPEN. SURGERY WAS NOT DELAYED AND WAS SUCCESSFULLY COMPLETED WITH EXTRA SUTURE. NO FRAGMENTS WERE GENERATED AND THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488386 GST GREEN RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. GST60G T4136G 10705036014713

    Patients

    Seq Age Sex Outcome Treatment
    1 Death