BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO

    MDR report key: 18317546 · Received December 13, 2023

    Report

    Report Number
    2242352-2023-01027
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    December 4, 2023
    Report Date
    March 14, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567701250
    PMA / PMN Number
    K153194
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TW ID# (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.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). CORRECTED SECTIONS: MEDICAL DEVICE ¿ PROBLEM CODE CORRECTED BY ADDING CODE "2930". THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 12/21/2023. AN INVESTIGATION WAS CONDUCTED ON 01/02/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED ON THE DEVICE. THE C-RING, HEATER WIRE, AND GRAY SILICONE INSULATION OF BOTH THE HOT AND COLD JAWS WERE OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE, ADAPTER, AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 3.0. THE DEVICE FAILED THE PRE-CAUTERY TEST. A TONE WAS AUDIBLE FROM THE POWER SUPPLY UPON ACTIVATION. IT PRODUCED VISIBLE STEAM AND HEAT WITH THE JAWS OPEN AND CLOSED, REGARDLESS OF THE TOGGLE POSITION. THE OPEN JAWS WERE OBSERVED TO GLOW BRIGHT ORANGE UPON ACTIVATION. NO EXCESS SMOKE WAS OBSERVED UPON ACTIVATION. AN ENGINEER EVALUATION WAS CONDUCTED ON 1/10/2024 WITH THE FOLLOWING RESULTS: THE JAWS ON THE COMPLAINT DEVICE WERE FOUND TO HAVE SOME SIGNS OF HEAT DAMAGE FROM THE DEVICE REMAINING ACTIVATED. THE COMPLAINT DEVICE WAS CONNECTED TO THE COMPLAINT LAB¿S HEMOPRO EXTENSION CABLE (C-VH-3030) AND THE HEMOPRO POWER SUPPLY (C-VH-3010). THE ON/OFF POWER SWITCH ON THE HEMOPRO POWER SUPPLY (C-VH-3010) WAS TOGGLED TO THE ON POSITION. THE COMPLAINT VH-3500 HEMOPRO TOOL SELF-ACTIVATED AND REMAINED ACTIVATED WHICH IS NOT NORMAL. NEXT, THE COMPLAINT VH-3500 HEMOPRO TOOL HANDLE WAS OPENED TO DETERMINE THE CAUSE OF THE HEATING ELEMENT ON THE PRIMARY JAW REMAINING ACTIVATED. USING A MULTIMETER (CALIBRATION ID# (B)(4)), ELECTRICAL CONTINUITY OF THE DEVICE¿S SWITCH WAS TESTED BETWEEN THE SWITCH¿S COMMON AND NORMALLY OPEN TERMINALS. THERE WAS ELECTRICAL CONTINUITY BETWEEN THE COMMON AND NORMALLY OPEN TERMINALS WHICH IS NOT NORMAL. IT WAS OBSERVED THAT WHEN THE SWITCH LEVER WAS DEPRESSED TO THE OPERATING POSITION, THE NORMAL CLICKING SOUND WHEN THE SWITCH¿S INTERNAL CONTACTS CLOSE TOGETHER WAS NOT HEARD. THIS IS NOT NORMAL AND INDICATES THAT THE INTERNAL MOVING CONTACT WAS JAMMED IN A POSITION THAT WAS CAUSING THE SWITCH TO REMAIN ACTIVATED. NEXT, THE BLACK COVER ON THE SWITCH WAS REMOVED TO FIND OUT WHAT WAS CAUSING THE SWITCH¿S INTERNAL MOVING CONTACT TO BE JAMMED IN A POSITION THAT WAS CAUSING THE SWITCH TO REMAIN ACTIVATED. IT WAS OBSERVED THAT THE SWITCH¿S NORMALLY OPEN TERMINAL HAD MOVED FROM ITS NORMAL LOCATION INSIDE THE SWITCH AND WAS POSITIONED UP AGAINST THE SWITCH MOVING CONTACT. THE SWITCH COULD NOT BE TURNED ¿OFF¿ BECAUSE THE SWITCH¿S NORMALLY OPEN TERMINAL WAS IN PHYSICAL DIRECT CONTACT WITH THE SWITCH¿S MOVING CONTACT. THIS WAS THE CAUSE OF DEVICE REMAINING ACTIVATED. THE CAUSE OF THE NORMALLY OPEN SWITCH TERMINAL MOVING WITHIN THE SWITCH BODY APPEARS TO BE FROM PROLONG HEAT APPLIED TO THE TERMINAL DURING SOLDERING. THE PROLONG HEAT APPLIED TO NORMALLY OPEN SWITCH TERMINAL MELTED THE PLASTIC THAT NORMALLY ANCHORS THE TERMINAL TO THE SWITCH BODY. BASED ON THE RETURNED CONDITION OF THE DEVICE, INVESTIGATION RESULTS, AND ENGINEERING EVALUATION, THE REPORTED FAILURE "DEVICE REMAINS ACTIVATED" WAS CONFIRMED, HOWEVER THE REPORTED FAILURE "ENVIRONMENTAL PARTICULATES; SMOKE" WAS NOT CONFIRMED. THE LOT # 3000340534 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, VASOVIEW HEMOPRO VH-3500 AS SOON AS THEY PLUGGED IT IN IT AUTOMATICALLY STARTED CAUTERIZING AND SMOKING AND WOULD NOT STOP. THEY HAD TO UNPLUG IT TO STOP IT. PRODUCT NOT USED ON PATIENT. NEW DEVICE. NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671795 VASOVIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-3500 3000340534 00607567701250

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown