BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5

    MDR report key: 92697 · Received May 20, 1997

    Report

    Report Number
    2647580-1997-00535
    Event Type
    Malfunction
    Date Received
    May 20, 1997
    Report Date
    April 24, 1997
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 INSTRUMENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO GIA 30-2.5 DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORPORATION NA P6A15

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN