BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 364029 · Received December 5, 2001

    Report

    Report Number
    1317214-2001-00057
    Event Type
    Malfunction
    Date Received
    December 5, 2001
    Date of Event
    October 31, 2001
    Report Date
    November 7, 2001
    Manufacturer
    CONMED CORP.
    Product Code
    HBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT. "THE ENDOSCOPIC CLIP APPLIER MISFIRED DURING A GALL BLADDER PROCEDURE. THE DUCT WAS SLIGHTLY DAMAGE AND BLED A SMALL AMOUNT. THE PROCEDURE WAS NOT ALTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54705 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other