BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE GAI 60-3.8

    MDR report key: 128002 · Received October 20, 1997

    Report

    Report Number
    2647580-1997-01305
    Event Type
    Malfunction
    Date Received
    October 20, 1997
    Date of Event
    September 20, 1997
    Report Date
    September 22, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A BOWEL RESECTION PROCEDURE. REPORTEDLY, THE INSTRUMENT WOULD NOT FIRE. THE SURGEON USED ANOTHER INSTRUMENT TO 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 GAI 60-3.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P6H479

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN