BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON TVP

    MDR report key: 80174 · Received April 1, 1997

    Report

    Report Number
    80174
    Event Type
    Injury
    Date Received
    April 1, 1997
    Report Date
    March 20, 1997
    Manufacturer
    ETHICON ENDO-SURGICAL, INC.
    Product Code
    GAG
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL REMOVAL OF LUNG TISSUE THE PULMONARY ARTERY WAS CLOSED WITH A SURGICAL STAPLER. THE PT WAS CLOSED AND WHEN TAKEN OFF TABLE WENT COMATOSE. PT HAD TO BE REENTERED AND FOUND STAPLE DID NOT CLOSE AND ABDOMINAL CAVITY FULL OF BLOOD. STAPLE REMOVED AND PT SUTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON TVP SURGICAL STAPLER GAG ETHICON ENDO-SURGICAL, INC. TVP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention