BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX ELC

    MDR report key: 552214 · Received October 29, 2004

    Report

    Report Number
    1317214-2004-00067
    Event Type
    Injury
    Date Received
    October 29, 2004
    Date of Event
    September 28, 2004
    Report Date
    September 28, 2004
    Manufacturer
    CONMED CORP.
    Product Code
    HBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    "DURING A LAP CHOLE, THE CLIPS DID NOT CLOSE CORRECTLY AND A SIGNIFICANT ARTERIAL BLEED OCCURRED. THE PT'S RECOVERY DOES NOT APPEAR TO BE ALTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED CORP. NA 0408132

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention