BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ILA 100 DISPOSABLE LOADING UNIT

    MDR report key: 169731 · Received May 26, 1998

    Report

    Report Number
    2647580-1998-00685
    Event Type
    Malfunction
    Date Received
    May 26, 1998
    Date of Event
    April 1, 1998
    Report Date
    April 29, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE INSTRUMENT MISFIRED. THE SURGEON APPLIED ANOTHER PROCEDURE DEVICE TO COMPLETE THE PROCEDURE. THE HOSPITAL HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ILA 100 DISPOSABLE LOADING UNIT DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA P7M84

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN