BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEX ELC

    MDR report key: 375876 · Received February 8, 2002

    Report

    Report Number
    1317214-2002-00003
    Event Type
    Injury
    Date Received
    February 8, 2002
    Date of Event
    January 8, 2002
    Report Date
    January 9, 2002
    Manufacturer
    CONMED CORPORATION
    Product Code
    HBT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE HEPATIC ARTERY WAS SEVERED BY THE JAWS OF THE ENDOSCOPIC CLIP APPLIER, WHEN THE CLIPS FAILED TO FEED THROUGH THE DEVICE. AN OPEN PROCEDURE WAS NEEDED TO REPAIR THE INJURY AND COMPLETE THE PROCEDURE. THE PATIENT HAD AN UNEVENTFUL RECOVERY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention