BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 19515435 · Received June 11, 2024

    Report

    Report Number
    2242352-2024-00658
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Report Date
    August 2, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID# (B)(4). SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP.

    Additional Manufacturer Narrative · 0

    TRACKWISE ID#: (B)(4). UPDATED SECTIONS: B-4, G-3, G-6, H-2, H-6, H-10, H-11. CORRECTED SECTION H-6: HEALTH EFFECT ¿ CLINICAL CODE FROM "1888" TO "4580". NO LOT # WAS REPORTED AND NO SPECIFIC EVENT SITE WAS REPORTED, SO THEREFORE NO SHIP HISTORY WAS CONDUCTED.

    Description of Event or Problem · 0

    RECEIVED INCROWD SURVEY 36836-EVH PMS- MAY 2024, WHERE THEY COMMENTED "HARD TO DO SPOT BLEEDING BECAUSE THE CAUTERIZE ONLY BETWEEN THE JAWS", WHEN ASKED ABOUT THE HARVESTING TOOL HEMOPRO 2 (VH-4000) ABILITY TO PERFORM SPOT CAUTERY/SPOT COAGULATION TO STOP SMALL BLEEDERS IN THE TUNNEL WALL.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172872 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.