BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 5183245 · Received January 30, 2004

    Report

    Report Number
    5183245
    Event Type
    Injury
    Date Received
    January 30, 2004
    Date of Event
    November 24, 2003
    Report Date
    January 15, 2004
    Manufacturer
    US SURGICAL
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2003, PT TO THE OPERATING ROOM FOR LAPAROSCOPIC VAGINAL HYSTERECTOMY. ON (B)(6) 2003, PT WENT BACK TO THE OPERATING ROOM BECAUSE OF BLEEDING. UPON EXAM OF THE PREVIOUS DAYS SUTURE LINE, THE DOCTOR DETERMINED THAT THE STAPLING LINE MISFIRED AND THE PT WAS BLEEDING FROM THAT AREA. ON (B)(6) 2003 EBL = 200CC. ON (B)(6) 2003 EBL = 850CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA CUT AND STAPLE GDW US SURGICAL P3E669

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R