BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE ENDO GIA II 60-4.8 SULU

    MDR report key: 328829 · Received April 24, 2001

    Report

    Report Number
    1219930-2001-00210
    Event Type
    Injury
    Date Received
    April 24, 2001
    Report Date
    March 30, 2001
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A BULAE RESECTION. REPORTEDLY, THE SMALL PART OF THE CARTRIDGE DETACHED INTO THE CAVITY. THE PT REQUIRED A RE-OPERATION ONE WEEK LATER TO RETRIEVE THE DETACHED PIECE WHICH WAS NOTED BY X-RAY. THE PRODUCT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18836 AUTO SUTURE ENDO GIA II 60-4.8 SULU ENDOSCOPIC STAPLER GCJ UNITED STATES SURGICAL CORP NA N0D138

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention