BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOVATIONS CLEARGLIDE VESSEL DISSECTOR

    MDR report key: 513281 · Received February 27, 2004

    Report

    Report Number
    513281
    Event Type
    Other
    Date Received
    February 27, 2004
    Date of Event
    November 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    ETHICON CARDIOVATIONS
    Product Code
    GDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PORTION OF THE JAW FROM THE DISPOSABLE BIPOLAR DEVICE IN THE ETHICON CARDIOVATIONS CLEARGLIDE EVH (ENDOSCOPIC VEIN HARVESTING) KIT BROKE WHILE IN USE. THE ENTIRE DEVICE WAS REMOVED FROM THE SURGICAL FIELD AND A REPLACEMENT DEVICE WAS THEN USED. NO PIECES ARE BELIEVED, BY THE PHYSICIAN'S ASSISTANT, TO HAVE BROKEN FREE FROM THE DEVICE. WHILE THE DEVICE WAS BEING EXAMINED BY THE SALES REP, THE BENT BACK PORTION OF THE BROKEN BIPOLAR DEVICE WAS BROKEN OFF AND PLACED IN SPECIMEN CUT BEFORE SENDING IT TO THE RISK MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVATIONS CLEARGLIDE VESSEL DISSECTOR VESSEL DISSECTOR GDI ETHICON CARDIOVATIONS KTV15 T4463K

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other