BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 18605588 · Received January 30, 2024

    Report

    Report Number
    18605588
    Event Type
    Malfunction
    Date Received
    January 30, 2024
    Date of Event
    January 19, 2024
    Report Date
    January 19, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    VASOVIEW HEMOPRO 2 VH-4000 LOT 3000349829. TIP OF BIPOLAR PIECE STARTED SEPARATING FROM SHAFT DURING NORMAL USE. THE DEVICE WAS PASSED OFF THE STERILE FIELD AND REPLACED WITH A NEW KIT. NO PARTS BROKE OFF AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988441 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000349829

    Patients

    Seq Age Sex Outcome Treatment
    1 18615 DA Unknown