BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LINEAR CUTTER

    MDR report key: 90338 · Received May 13, 1997

    Report

    Report Number
    MW1011281
    Event Type
    Injury
    Date Received
    May 13, 1997
    Date of Event
    April 29, 1997
    Report Date
    May 2, 1997
    Manufacturer
    J & J
    Product Code
    KOG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    S/P LAPAROSCOPY VAGINAL HYSTERECTOMY, PT DEVELOPED BLEEDING S/S IN RECOVERY WITH RETURN TO OR. FOUND DURING OPEN PROCEDURE THE ARTERY PULLED OUT OF STAPLE LINE. THERE IS A QUESTION AS TO "STAPLE PULLING, SMALL PUNCTURE..." MFR CALLED IMMEDIATELY WITH REPRESENTATIVE SPEAK WITH PHYSICIAN & EVALUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER DISPOSABLE STAPLER KOG J & J * J45N4W,K-4631K,K-4521H,J-45M3X

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention