BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 17781735 · Received September 20, 2023

    Report

    Report Number
    2242352-2023-00802
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 31, 2023
    Report Date
    December 5, 2023
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    UDI-DI
    00607567700406
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, D10, G4, G7, H2, H3, H6, H10 THE LOT # 3000305145 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    TW ID# 884291. 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). UPDATED SECTIONS: B4,, G4, G7. H2, H3, H6, H10, H11 CORRECTED SECTIONS: D10 THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 11/13/2023. AN INVESTIGATION WAS CONDUCTED ON 11/14/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED ON THE DEVICE. EVIDENCE OF CHARRED MATERIAL WAS OBSERVED BETWEEN THE JAWS. THE HEATER WIRE AND CLEAR SILICONE INSULATION OF THE JAWS WERE OBSERVED TO BE INTACT WITH NO VISUAL DEFECTS OBSERVED. 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 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 WITH NO EXCESSIVE SMOKE OBSERVED. A TONE WAS AUDIBLE FROM THE POWER SUPPLY UPON ACTIVATION. 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 THE 10-SECOND COOLING PERIOD WITH NO INCIDENT EACH TIME. THE JAWS WERE GENTLY CLEANED OF DEBRIS AND CHAR WITH A SALINE AND GAUZE PAD AS INDICATED IN THE DIRECTION FOR USE (CV000008979). AN ACTIVATION AND TRANSECTION CAPABILITY TEST WAS PERFORMED OVER FOUR (4) REPETITIONS USING "MAX LIFE TEST METHOD STM2048073 REV AA. 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 REV W. THE RESISTANCE VALUE WAS MEASURED AT .682 OHMS WHICH IS WITHIN SPECIFICATION. THE DEVICE PASSED THE TEMPERATURE MEASUREMENTS TEST. THE DISPLAYED TEMPERATURE INCREASED AND TURNED GREEN WITHIN THE 2 SECOND SPECIFIED TIMEFRAME. THE DISPLAYED TEMPERATURE DECREASED ONCE THE TOGGLE SWIVEL WAS RELEASED. BASED ON THE RETURNED CONDITION OF THE DEVICE, THE REPORTED FAILURES "ELECTRICAL PROBLEM" AND "MATERIAL TWISTED/BENT; WIRE" WERE NOT CONFIRMED. THE LOT # 3000305145 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

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CAUTERY ON THE JAWS STOPPED WORKING. THEY PULLED IT OUT, AND WHERE THE JAW MEETS THE NECK, IT SNAPPED. NO COMPONENTS DETACHED. THE JAWS WOULD OPEN AND CLOSE A LITTLE, BUT THE CAUTERY WOULDN'T WORK. THERE WAS A 10 MIN DELAY UNTIL ANY NEW KIT WAS OPENED. NO PATIENT HARM/EFFECTS DUE TO THE DEFECTIVE DEVICE.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614518 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VH-4000 3000305145 00607567700406

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Prefer Not To Disclose UNKNOWN.