BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE POWERED LDS 15W

    MDR report key: 127359 · Received October 16, 1997

    Report

    Report Number
    1219930-1997-02261
    Event Type
    Malfunction
    Date Received
    October 16, 1997
    Report Date
    September 17, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    11/05/1997-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. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE POWERED LDS 15W DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORP. NA N7H55

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN