BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GAI II 45-3.5 DLU

    MDR report key: 229847 · Received June 29, 1999

    Report

    Report Number
    1219161-1999-00547
    Event Type
    Malfunction
    Date Received
    June 29, 1999
    Date of Event
    May 31, 1999
    Report Date
    June 4, 1999
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A THORACOSCOPIC BULLECTOMY PROCEDURE. REPORTEDLY, THE INSTRUMENT BROKE AND A COMPONENT DISENGAGED INTO THE PATIENT'S CAVITY. THE SURGEON WAS ABLE TO RETRIEVE THE COMPONENT AND COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GAI II 45-3.5 DLU DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. NA U9D101

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR