BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW POWER SUPPLY

    MDR report key: 1950778 · Received December 30, 2010

    Report

    Report Number
    MW5018800
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    October 5, 2010
    Report Date
    December 30, 2010
    Manufacturer
    GUIDANT
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING ENDOSCOPIC HARVESTING OF THE LEFT SAPHENOUS VEIN, SMOKE WAS OBSERVED COMING FROM THE TIP OF THE HEMOPRO TUNNELING AND COAGULATING DEVICES. THESE DEVICES WERE IMMEDIATELY REMOVED FROM THE PT'S LEG AND OPERATIVE FIELD. CONTINUED THE CASE WITHOUT FURTHER INCIDENT TO THE PT. DATES OF USE: ONE DAY - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: SAPHENOUS VEIN HARVESTING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED? YES. EVENT REAPPEARED AFTER REINTRODUCTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW POWER SUPPLY MAQUET VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI GUIDANT VH-3010

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR