BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ENDO UNIVERSAL 65-4.8

    MDR report key: 95213 · Received May 30, 1997

    Report

    Report Number
    1219161-1997-00616
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    April 1, 1997
    Report Date
    May 2, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    6/23/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    DURING AN UNSPECIFIED PROCEDURE, THE CARTRIDGE DISENGAGED. THE SURGEON APPLIED ANOTHER DEVICE WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ENDO UNIVERSAL 65-4.8 DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN