BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 23336220 · Received October 20, 2025

    Report

    Report Number
    2242352-2025-0001139
    Event Type
    Malfunction
    Date Received
    October 20, 2025
    Date of Event
    September 24, 2025
    Report Date
    November 7, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE - (B)(4). UPDATED FIELD: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 10/21/2025. AN INVESTIGATION WAS CONDUCTED ON 10/21/2025. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON THE HARVESTING DEVICE HANDLE. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE CLEAR INTACT SILICONE INSULATION ON BOTH THE COLD AND HOT JAWS. THERE WAS HEAVY CHAR OBSERVED ON THE INTACT HEATER WIRE AT THE BASE OF THE HEATER WIRE, THE HEATER WIRE WAS OBSERVED TO BE LIFTED FROM THE HOT JAW AT THE CENTER OF THE HOT JAW BUT REMAINED ATTACHED AT THE BASE AND TIP OF THE HOT JAW. 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. NO EXCESSIVE SMOKE AND/OR STEAM WERE OBSERVED DURING THE TESTING. 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 STM2048073. 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 90523436. THE RESISTANCE VALUE WAS MEASURED AT 0.68 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 "MATERIAL TWISTED/ BENT WIRE" WAS NOT CONFIRMED. THE LOT # 3000499425 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

    (B)(4). THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 ENERGY WIRE POPPED OFF OF THE JAWS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. MINIMAL DELAY IN CASE TO OPEN A NEW DEVICE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2354912 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000499425 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female UNKNOWN.