BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE ROTICULATOR 55-4.8

    MDR report key: 99313 · Received June 18, 1997

    Report

    Report Number
    2647580-1997-00678
    Event Type
    Malfunction
    Date Received
    June 18, 1997
    Date of Event
    May 20, 1997
    Report Date
    May 21, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    06/25/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A COLON RESECTION PROCEDURE. REPORTEDLY, THE STAPLES MISFIRED. THE SURGEON OVERSEWED TO COMPLETE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE ROTICULATOR 55-4.8 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA P6E197

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN