BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX ELC

    MDR report key: 382547 · Received March 14, 2002

    Report

    Report Number
    1317214-2002-00016
    Event Type
    Malfunction
    Date Received
    March 14, 2002
    Date of Event
    February 8, 2002
    Report Date
    February 14, 2002
    Manufacturer
    CONMED CORPORATION
    Product Code
    HBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "THE SURGEON COULD NOT GET THE CLIPS TO CLOSE COMPLETELY ON THE TARGET TISSUE. MALFORMED CLIPS WERE REMOVED FROM THE SURGICAL SITE. ENOUGH DID CLOSE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY AND THE PROCEDURE WAS COMPLETED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REFLEX ELC ENDOSCOPIC CLIP APPLIER HBT CONMED CORPORATION NA 011221

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other