BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE PREMIUM MULTIFIRE TA 90-3.5

    MDR report key: 134800 · Received November 24, 1997

    Report

    Report Number
    1219930-1997-02548
    Event Type
    Malfunction
    Date Received
    November 24, 1997
    Date of Event
    October 30, 1997
    Report Date
    October 30, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    12/15/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE PREMIUM MULTIFIRE TA 90-3.5 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA N6F189

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN