BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 21351488 · Received February 10, 2025

    Report

    Report Number
    2242352-2025-0000125
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 6, 2025
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED SECTION: H6 D4 - HEALTH EFFECT ¿ IMPACT CODES REMOVED CODE "4629". THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 01/28/2025. AN INVESTIGATION WAS CONDUCTED ON 02/21/2205. A VISUAL INSPECTION WAS CONDUCTED. BOTH THE HARVESTING DEVICE AND CANNULA WAS RETURNED FOR EVALUATION. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED ON BOTH DEVICES. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT CANNULA OR INTACT C-RING. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT JAWS SILICONE INSULATION. THE HEATER WIRE WAS OBSERVED TO BE LIFTED AT THE CENTER OF THE HOT JAW DUE TO CLINICAL USE. THERE WERE NO VISUAL DEFECTS OBSERVED. 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 (B)(4). 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 (B)(4). 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 "ELECTRICAL /ELECTRONIC PROPERTY PROBLEM" WAS NOT CONFIRMED. THE LOT # 3000444151 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.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (VH-4000), TIPS NOT HEATING UP. SETTING WAND UP TO 5 AND STILL WASN'T CUTTING/BURNING THRU SKIN. SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM BUT THE PROCEDURE WAS DELAYED BY 15 MINUTES.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2 (VH-4000), TIPS NOT HEATING UP. SETTING WAND UP TO 5 AND STILL WASN'T CUTTING/BURNING THRU SKIN. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM BUT THE PROCEDURE WAS DELAYED BY 15 MINUTES..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657857 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000444151 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male UNKNOWN.