BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 WITH VASOSHIELD

    MDR report key: 3912112 · Received May 13, 2014

    Report

    Report Number
    2242352-2014-00540
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD. A VISUAL INSPECTION DETERMINED THAT THE HEATING WIRE BOWED AWAY FROM THE SILICONE BOOT; THE HEATING WIRE REMAINED ATTACHED TO THE TIP OF THE HOT JAW. MOST OF THE COLD SILICONE BOOT WAS DETACHED FROM THE JAW. ADDITIONAL EVALUATION IS REQUIRED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE INSULATION ON THE JAWS OF THE VASOVIEW HEMOPRO 2 WITH VASOSHIELD BECAME LOOSE. NOTHING FELL INTO THE PT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285528 VASOVIEW HEMOPRO 2 WITH VASOSHIELD ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4001 25093402

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR