BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSUTURE

    MDR report key: 1037579 · Received May 1, 2008

    Report

    Report Number
    MW5006536
    Event Type
    Injury
    Date Received
    May 1, 2008
    Date of Event
    March 27, 2008
    Report Date
    May 1, 2008
    Manufacturer
    UNITED STATES SURGICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2008, WE WERE DOING A PERFORATED VISCUS PROCEDURE AND MD ASKED FOR A QIA 80 WHICH WAS USED INITIALLY AND WORKED FINE. THEN, MD REQUESTED A RELOAD FOR IT. WHEN THE STAPLER WAS FIRED, THE STAPLE LINE WAS NOT COMPLETED. HE THEN HAD TO RESTAPLE WITH A GIA 60 AND HAND SEW. AT ABOUT ONE WEEK LATER, THE PT WAS READMITTED TO THE HOSPITAL SECONDARY TO NAUSEA/VOMITING AND INABILITY TO TOLERATE A CLEAR LIQUID DIET. FOUR DAYS LATER, THIS PT UNDERWENT AN EXPLORATORY LAPAROTOMY FOR A LEAK TRANSVERSE COLON ANASTOMOSIS AT STAPLE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOSUTURE RELOADABLE STAPLER GAG UNITED STATES SURGICAL GIA803.8 P8B0044
    2 AUTOSUTURE SINGLE USE LOADING UNIT GAG UNITED STATES SURGICAL GIA803.8 P2B0633

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization