BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO GIA II 60-4.8

    MDR report key: 280639 · Received May 31, 2000

    Report

    Report Number
    1219161-2000-00458
    Event Type
    Malfunction
    Date Received
    May 31, 2000
    Date of Event
    April 28, 2000
    Report Date
    May 1, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A WEDGE RESECTION. REPORTEDLY, THE INSTRUMENT DID NTO FIRE. 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 ENDO GIA II 60-4.8 DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN