BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX AEC 35

    MDR report key: 51779 · Received November 26, 1996

    Report

    Report Number
    51779
    Event Type
    Injury
    Date Received
    November 26, 1996
    Date of Event
    November 12, 1996
    Report Date
    November 26, 1996
    Manufacturer
    RICHARD ALLAN MEDICAL
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ENDO STAPLER DID NOT ADEQUATELY STAPLE THE LIGAMENTS ON THE LEFT SIDE (INFUNDIBULOPELVIC LIGAMENT) AND THEREFORE ENDO CLIPS WERE PLACED WITH GOOD HEMOSTASIS. EXPIRATION DATE: 10/14/2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX AEC 35 CARTICULATING ENDOSCOPIC LINEAR CUTTER GAG RICHARD ALLAN MEDICAL REFLEX AEC 35 140CT01, 05SEP01,

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention