BEUDAMED
    FDA Adverse Event Death Summary report: N

    GST GREEN RELOAD, 60MM, 6 ROW

    MDR report key: 9928070 · Received April 6, 2020

    Report

    Report Number
    3005075853-2020-02014
    Event Type
    Death
    Date Received
    April 6, 2020
    Date of Event
    March 10, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014713
    PMA / PMN Number
    K110385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/15/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: RESPONSE RECEIVED FROM SALES REP: WHAT WAS THE INITIAL SURGICAL PROCEDURE? VERTICAL GASTRECTOMY. WHAT WAS THE PRODUCT CODE OF STAPLER USED IN INITIAL PROCEDURE? CAN LOT/BATCH BE PROVIDED? FIRST PROCEDURE: KIT BRKPW05GSTV2. FIRST STAPLING: GST60G. LOT: T40L9W 2022/06/30. WERE THERE ANY DIFFICULTIES WITH DEVICE TO INCLUDE STAPLE FORMATION? NO. WAS BUTTRESSING MATERIAL USED? NO. HOW WERE THE STAPLE LINE ISSUES IDENTIFIED? TOMOGRAPHY AND REOPERATION ON THE NINTH POSTOPERATIVE DAY. DURING THE REOPERATION, WHAT WAS FOUND AND HOW WAS IT ADDRESSED? FIRST SHOT DEHISCENCE, GREEN CHARGE. CAVITY WASHING AND DRAINAGE. CAN A DETAILED TIMELINE OF EVENTS BE PROVIDED? WHAT IS THE PATIENT AGE, GENDER, BMI? YOUNG FEMALE WITH BMI 40. DURING 3RD SURGICAL PROCEDURE, WHAT WAS FOUND AND HOW WAS IT ADDRESSED? PERITONITIS. CAVITY WASHING, DRAINAGE AND FOOD JEJUNOSTOMY. ARE ANY PHOTOS, VIDEO AVAILABLE OF INITIAL PROCEDURE? NO. WAS AN AUTOPSY PERFORMED? IF SO, CAN THE RESULTS BE SHARED? NO. DOES THE SURGEON BELIEVE THAT AN ALLEGED DEFICIENCY OF ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH? YES. I ALREADY HAVE BEEN REPORTING THIS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 4/6/2020. BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. 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. WHAT WAS THE INITIAL SURGICAL PROCEDURE? WHAT WAS THE PRODUCT CODE OF STAPLER USED IN INITIAL PROCEDURE? CAN LOT/BATCH BE PROVIDED? WERE THERE ANY DIFFICULTIES WITH DEVICE TO INCLUDE STAPLE FORMATION? WAS BUTTRESSING MATERIAL USED? HOW WERE THE STAPLE LINE ISSUES IDENTIFIED? DURING THE REOPERATION, WHAT WAS FOUND AND HOW WAS IT ADDRESSED? CAN A DETAILED TIMELINE OF EVENTS BE PROVIDED? WHAT IS THE PATIENT AGE, GENDER, BMI? DURING 3RD SURGICAL PROCEDURE, WHAT WAS FOUND AND HOW WAS IT ADDRESSED? ARE ANY PHOTOS, VIDEO AVAILABLE OF INITIAL PROCEDURE? WAS AN AUTOPSY PERFORMED? IF SO, CAN THE RESULTS BE SHARED? DOES THE SURGEON BELIEVE THAT AN ALLEGED DEFICIENCY OF ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH? WOULD THE SURGEON BE INTERESTED IN SPEAKING TO ETHICON MEDICAL AND ENGINEERING TO DISCUSS EVENT?

    Description of Event or Problem · 1

    AN AUXILIARY SURGEON REPORTED THAT THE PATIENT DIED. ACCORDING TO HIM, THE STAPLE LINE OF THE FIRST STAPLED OPENED DURING THE POST-SURGICAL PERIOD. ACCORDING TO AT WHO FOLLOWED THE PROCEDURE, THERE WAS NO COMPLAINT OR BLEEDING DURING THE PROCEDURE. THE PATIENT WENT FOR LAPAROSCOPY AFTER 11 DAYS, AND AFTER 02 DAYS HE RETURNED FOR EXPLORATORY LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392577 GST GREEN RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. GST60G T40L9W 10705036014713

    Patients

    Seq Age Sex Outcome Treatment
    1 Death