BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNIA

    MDR report key: 8621770 · Received May 17, 2019

    Report

    Report Number
    1219930-2019-03001
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 17, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543805
    PMA / PMN Number
    K160176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING THE FIFTH FIRING ON A LAPAROSCOPY ASSISTED DISTAL GASTRECTOMY, THE KNIFE RESECTED TISSUE FOR ABOUT 1 CM WITHOUT ANY STAPLES ON THE LEFT 3 ROWS. MOST OF THE STAPLES WERE NOT FORMED, THE STAPLES WERE FORMED IN V SHAPE JUST WHEN IT WAS FIRED. THERE WAS A BLEEDING FROM THE SITE WHICH WAS RESECTED WITH A KNIFE BUT IT WAS LESS THAN 200 CC. THEY PERFORMED A TEMPORARY CLOSURE AGAIN WITH A NEEDLE THREAD. A LEAK TEST WAS PERFORMED AND SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES. IT WAS ALSO STATED THAT THERE WAS A TISSUE DAMAGE. THE ENTRY HOLE WAS CLOSED WITH ANOTHER PRODUCT. AT PRESENT, THE PATIENT IS UNDER OBSERVATION BECAUSE THERE IS A POSSIBILITY OF POST-OPERATIVE LUMEN HEMORRHAGE AND STENOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414765 SIGNIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGADAPTSTND 10884521543805

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention