BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE TA PREMIUM 30-V3 DISPOSABLE LOADING UNIT

    MDR report key: 172432 · Received June 12, 1998

    Report

    Report Number
    2647580-1998-00768
    Event Type
    Malfunction
    Date Received
    June 12, 1998
    Report Date
    May 15, 1998
    Manufacturer
    UNITED STATES SURGICAL CORP
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    08/06/1999-SUPPLEMENTAL REPORT #1 SENT TO FDA. DEVICE NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TA PREMIUM 30-V3 DISPOSABLE LOADING UNIT DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP NA P6K104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN