BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 16205843 · Received January 19, 2023

    Report

    Report Number
    2242352-2023-00051
    Event Type
    Malfunction
    Date Received
    January 19, 2023
    Date of Event
    December 26, 2022
    Report Date
    February 16, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE ID (B)(6). 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

    (B)(4). UPDATED SECTION: B4, D10, G4, G7, H2, H6, H10 THE LOT #3000279399 HISTORY RECORD REVIEW WAS COMPLETED. THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE THE VASOVIEW HEMOPRO 2 DID NOT ACTIVATE (CUT AND SEAL). THE JAWS OF THE HARVESTING TOOL WERE NOT OPEN (EVEN SLIGHTLY) DURING THE INSERTION OF THE TOOL. NO RESISTANCE NOTED. THEY EXCHANGED THE BLACK EXTENSION CABLE FOR A NEW CABLE. STILL WOULD NOT WORK. THEY OPENED A NEW HP-2 (VH-4000), THE DEVICE WORKED. NO HARM TO THE PATIENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166061 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000279399 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male