BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 3905437 · Received May 28, 2014

    Report

    Report Number
    2242352-2014-00620
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    WY-2013-47
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL IS COMPLETED. A LOT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION ((B)(6)) ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO 2 WASN'T BURNING AS WELL AS IT TYPICALLY DOES, MOSTLY WHILE TRYING TO EXPAND THE TUNNEL ON THE ANTERIOR WALL. EXTRA SMOKE WAS NOTED IN THE TUNNEL AND WHILE PULLING OUT THE DEVICE TO CLEAN THE TIP IT WAS OBSERVED THAT THE METAL STRIPS ON THE TIP SEPARATED FROM THE JAWS OF THE DEVICE. NOTHING FELL INTO THE PT. THE TISSUE LOOKED LIKE IT CONTINUED TO BURN EVEN AFTER THE DEVICE WAS RETRACTED FROM THE TUNNEL. 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
    314919 VASOVIEW HEMOPRO 2 ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25094120

    Patients

    Seq Age Sex Outcome Treatment
    1