BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE MULTIFIRE GIA 80-4.8

    MDR report key: 168798 · Received May 20, 1998

    Report

    Report Number
    2647580-1998-00674
    Event Type
    Malfunction
    Date Received
    May 20, 1998
    Date of Event
    April 23, 1998
    Report Date
    April 23, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    1/25/1999- SUPPLEMENTAL REPORT SENT TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A WHIPPLE PROCEDURE. REPORTEDLY, THE INSTRUMENT PARTIALLY FIRED. THE HOSPITAL HAS REPORTED NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE GIA 80-4.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P7J394

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN