BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMPRO

    MDR report key: 3810983 · Received March 23, 2014

    Report

    Report Number
    2242352-2014-00306
    Event Type
    Malfunction
    Date Received
    March 23, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT TOWARDS THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, IT WAS OBSERVED THAT THE SILICONE PART OF THE JAW WAS BURNT. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. IT WAS NOTED THAT IT WAS ONLY ACTIVATED 4-5 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171303 VASOVIEW HEMPRO ENDOCSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR VH-3000-W 25088148

    Patients

    Seq Age Sex Outcome Treatment
    1 NI