BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GST GOLD RELOAD, 60MM, 6 ROW

    MDR report key: 7540258 · Received May 24, 2018

    Report

    Report Number
    3005075853-2018-10138
    Event Type
    Injury
    Date Received
    May 24, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 12, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036014697
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: ONLY MONTH AND YEAR ARE KNOWN. IT IS ASSUMED FIRST DAY OF THE MONTH (MONTH) THAT THE COMPLAINT WAS RECEIVED. BATCH # UNK. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 PATIENTS HAVE EXPERIENCED POST-OP BLEEDING WITHIN THE PAST 2 WEEKS WHICH REQUIRED A TRANSFUSION. ONE IS CONSIDERED AN INTRALUMINAL GI BLEED. THE OTHER TWO ARE SUSPECTED TO BE BLEEDING WITHIN THE INTRAPERITONEAL CAVITY. ANY BLEEDING DURING THE PROCEDURE WOULD HAVE BEEN CONTROLLED WITH ONE (OR A COMBINATION) OF THE FOLLOWING TECHNOLOGIES...HORIZON CLIPS, SUTURE, HARMONIC, ELECTROSURGERY, ARGON, SURGICEL, AND/OR EVICEL. HE CAN¿T SAY FOR CERTAIN THAT THE BLEEDING IS RELATED TO THE STAPLE LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385308 GST GOLD RELOAD, 60MM, 6 ROW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036014697

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention