BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDO GIA UNIVERSAL AUTO SUTURE, 12MM

    MDR report key: 385737 · Received March 29, 2002

    Report

    Report Number
    385737
    Event Type
    Other
    Date Received
    March 29, 2002
    Date of Event
    March 27, 2002
    Report Date
    March 28, 2002
    Manufacturer
    UNITED STATES SURGICAL, TYCO HEALTHCARE GROUP LP
    Product Code
    GAO
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THORACOSCOPY, SURGEON PLACED INSTRUMENT IN PORT, CLAMPED AROUND LUNG TISSUE AND FIRED INSTRUMENT. INSTRUMENT WOULD NOT RELEASE. PROCEDURE CONVERTED TO THORACOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA UNIVERSAL AUTO SUTURE, 12MM AUTO SUTURE (STAPLE GUN) GAO UNITED STATES SURGICAL, TYCO HEALTHCARE GROUP LP * N2B324
    2 ENDO GIA RETICULATOR, 60-3.5 (60 STAPLES 3.5MM) AUTO SUTURE (CARTRIDGE) GAO UNITED STATES SURGICAL, TYCO HEALTHCARE GROUP LP * U1K14

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other