BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 18131794 · Received November 13, 2023

    Report

    Report Number
    MW5148095
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    November 2, 2023
    Report Date
    November 2, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE NURSE PRACTIONER WAS HARVESTING THE SAPHENOUS VEIN UTILIZING THE VASOVIEW HEMOPRO 2 (VH-4000). HE NOTICED THAT THE CAUTERIZING CONTACT ELECTRODE HAD SEPARATED FROM THE JAW OF THE INSTRUMENT. PT DID NOT APPEAR TO BREAK OFF WHILE INSIDE THE PT'S LEG. HE HAD FINISHED THE HARVEST WITHOUT ANY ADVERSE OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154200 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC. VH-4000 3000343889

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male