BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO SUTURE TA LONG 90-3.5

    MDR report key: 133694 · Received November 18, 1997

    Report

    Report Number
    1219161-1997-01712
    Event Type
    Malfunction
    Date Received
    November 18, 1997
    Date of Event
    October 21, 1997
    Report Date
    October 22, 1997
    Manufacturer
    UNITED STATES SURGICAL CORPORATION
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING A LOBECTOMY PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM. NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE TA LONG 90-3.5 DISPOSABLE SURGICAL STAPLER GAG UNITED STATES SURGICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN