BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DST SERIES

    MDR report key: 2110394 · Received May 26, 2011

    Report

    Report Number
    2110394
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 26, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERI-STRIPS WERE USED ON THE GIA8048L GREEN STAPLER. THE STAPLER FIRED, BUT THE STRIPS DID NOT ADHERE TO STAPLE LINE. THE SURGEON THOUGHT THE PROBLEM WAS WITH THE PERI-STRIPS, NOT THE STAPLE LOADS. IT JUST PEELED AWAY WHEN THE STAPLES WERE FIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DST SERIES STAPLER, SURGICAL GDW COVIDIEN GIA8048L *
    2 PERI-STRIPS REINFORCEMENT STAPLER MESH FTM SYNOVIS SURGICAL INNOVATIONS PSD8006-U-V *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR