BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GIA 30-3.5

    MDR report key: 250061 · Received November 10, 1999

    Report

    Report Number
    1219161-1999-00997
    Event Type
    Malfunction
    Date Received
    November 10, 1999
    Date of Event
    October 20, 1999
    Report Date
    October 27, 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 TOTAL BLADDER RESECTION. REPORTEDLY, THE APPROXIMATING LEVER BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GIA 30-3.5 DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN