BEUDAMED
    FDA Adverse Event Death Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 23927130 · Received December 30, 2025

    Report

    Report Number
    2242352-2025-0001332
    Event Type
    Death
    Date Received
    December 30, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 30, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TW #(B)(4). UPDATED SECTIONS: B4, G3, G6, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON (B)(6) 2025. AN INVESTIGATION WAS CONDUCTED ON (B)(6) 2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND SLIGHT EVIDENCE OF BLOOD WAS OBSERVED ON THE JAWS AS WELL AS ON THE HARVESTING DEVICE HANDLE. THE HEATER WIRE WAS OBSERVED TO BE INTACT. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE CLEAR INTACT SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE DIRECTION FOR USE (DFU) WITH A REFERENCE CABLE, ADAPTER, AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 3.0. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM AND HEAT DURING TEN (10) 3-SECOND ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. TO EVALUATE THE SAFETY SHUT DOWN SYSTEM, A POLYFUSE ACTIVATION TEST WAS PERFORMED 5 TIMES OVER 10 MINUTES. THE DEVICE SHUT OFF AFTER THE PERIOD OF SUSTAINED ACTIVATION AND REACTIVATED AFTER 10-SECOND COOLING PERIOD WITH NO INCIDENT EACH TIME. AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER FOUR (4) REPETITIONS USING "MAX LIFE TEST METHOD. THE DEVICE SUCCESSFULLY TRANSECTED TISSUE FOUR (4) TIMES. A TEMPERATURE AND RESISTANCE TEST WAS CONDUCTED TO EVALUATE THE DEVICE FUNCTION PER HEMOPRO 2 FINAL TEST. THE RESISTANCE VALUE WAS MEASURED AT 0.69 OHMS WHICH IS WITHIN SPECIFICATION. THE DEVICE PASSED THE TEMPERATURE MEASUREMENTS TEST. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "ELECTRICAL /ELECTRONIC PROPERTY PROBLEM" WAS NOT CONFIRMED. THE LOT # 3000510057 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.

    Additional Manufacturer Narrative · 0

    TW (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. INITIAL REPORTER EXCEEDS CHARACTER LIMITATIONS: (B)(6). EVENT SITE NAME EXCEEDS CHARACTER LIMITATIONS: (B)(6).

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING A PROCEDURE VASOVIEW HEMOPRO 2 TIMED OUT, ALLOWED TIME TO RECOVER, CONTINUED TO TIME OUT UNTIL UNABLE TO PROCEED WITH HARVESTING. THIS RESULTED IN DELAYED CARE DURING PROCEDURE, KIT TIMED OUT AND WAS UNABLE TO DELIVER ADEQUATE CAUTERIZATION. THE POWER SOURCE SETTING DURING THE CASE WAS 3. A PRE-TEST PRIOR TO USE PERFORMED. THE BEEPING SOUND WAS NOT HEARD WHEN THE TOGGLE WAS PULLED BACK TO ACTIVATE THE DEVICE WHEN IT TIMED OUT. THERE WAS OPENED A 2ND KIT TO COMPLETE PROCEDURE. THERE WAS A PROCEDURAL DELAY. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1836046 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000510057 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male NO CONCOMITANT PRODUCTS WERE USED.