BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 359992 · Received November 9, 2001

    Report

    Report Number
    1317214-2001-00049
    Event Type
    Malfunction
    Date Received
    November 9, 2001
    Date of Event
    January 1, 2001
    Report Date
    October 11, 2001
    Manufacturer
    CONMED COMPANY
    Product Code
    HBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "DURING A SURGICAL PROCEDURE THE CLIP APPLIER EJECTED ALL 20 CLIPS AT ONCE INTO THE SURGICAL SITE. ALL CLIPS WERE RETRIEVED AND THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50103 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED COMPANY NA 107100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other