BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 4951537 · Received July 28, 2015

    Report

    Report Number
    2242352-2015-00599
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    June 26, 2015
    Report Date
    June 29, 2015
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USE WERE OBSERVED. SIGNIFICANT AMOUNTS OF TISSUE AND CHARRED BLOOD WERE OBSERVED ON THE HEATING ELEMENT. NO VISIBLE DEFECTS WERE OBSERVED. THE DEVICE WAS EVALUATED FOR ELECTRICAL FUNCTION. THE DEVICE FAILED A PRE-CAUTERY TEST; IT WAS OBSERVED THAT THE HEATING ELEMENT DID NOT TURN ORANGE FOR ONE ACTIVATION OUT OF 4 ATTEMPTS; HOWEVER A SMALL ORANGE GLOW WAS OBSERVED NEAR THE BASE OF THE HEATER WIRE. SMOKE WAS PRODUCED AND WARMTH WAS FELT IMMEDIATELY BELOW THE JAWS THROUGH THE PLASTIC SHAFT. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT WAS CONFIRMED FOR THE REPORTED FAILURE MODE "FAILURE TO CAUTERIZE" AND "INTERMITTENT ACTIVATION." (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIES VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 CAUTERY WORKED INTERMITTENTLY AND POWER SUPPLY MADE WEIRD NOISES. LARGE BRANCHES WERE NOT SEALED, WHICH CREATED EXCESS BLEEDING IN THE LEG. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489418 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR LLC C-VH-4000 25115534

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other