BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 45MM 34CM SHAFT

    MDR report key: 10720836 · Received October 22, 2020

    Report

    Report Number
    3005075853-2020-05491
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 28, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014317
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE 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. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON USUALLY WAIT 15 SECONDS BEFORE FIRING? YES. DOES THE SURGEON FIRE OR USE A CONTINUOUS SHOT? I DO NOT HAVE THIS INFORMATION. WHAT COLOR AND CODE OF THE PRODUCT OR CARTRIDGE WAS USED DURING THE PROCEDURE? PSE45A. WAS REINFORCEMENT MATERIAL USED? NO. HOW WAS BLEEDING TREATED INTRAOPERATIVELY? I DO NOT HAVE THIS INFORMATION. HOW WAS THE LEAK IDENTIFIED? I DO NOT HAVE THIS INFORMATION. WERE ANY DIFFICULTIES OBSERVED WITH THE DEVICE DURING THE INITIAL PROCEDURE TO INCLUDE STAPLE FORMATION? DOCTOR ALREADY USED TO USE THIS STAPLER, BUT I DO NOT HAVE THIS INFORMATION IN THIS CASE. WAS A LEAK TEST PERFORMED? IF SO, WHAT WAS THE RESULT? YES. BLUE LEAK. DURING THE REOPERATION, WERE THERE ANY PROBLEMS WITH STAPLE FORMATION? I DO NOT HAVE THIS INFORMATION. HOW WAS THE LEAK HANDLED IN THE REOPERATION? I DO NOT HAVE THIS INFORMATION. WHAT IS THE PATIENT'S CURRENT STATE? I DO NOT HAVE THIS INFORMATION. IN THIS PATIENT, THERE WAS NO FISTULA, BUT A STAPLE LINE DEHISCENCE. AND NEED FOR REOPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE LAST 4 BYPASS SURGERIES THE DOCTOR PERFORMED, SHE REPORTS HAVING HAD 3 LEAKS IN THE GASTROENTEROANASTOMOSIS (TWO OF THEM WERE CORRECTED DURING THE SURGERY AND THE OTHER ONE HAD A FISTULA AND THE PATIENT NEEDED TO BE REOPERATED). DOCTOR SAYS THAT THE STAPLE LINES ARE BLEEDING TOO MUCH, BEYOND NORMAL. GASTROENTEROANASTOMOSIS LEAKAGE, FISTULA AND THE PATIENT NEEDED TO BE RE OPERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181245 PWRD ECH FLEX 45MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PSE45A 10705036014317

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention