BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 6 PRO

    MDR report key: 3080964 · Received April 24, 2013

    Report

    Report Number
    2242352-2013-00386
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K091733
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    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. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY WHICH WOULD BE CONSIDERED RELATED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SCOPE WASHER ON THE VASOVIEW 6 PRO WAS NOT FUNCTIONING PROPERLY. THE ISSUE OCCURRED EARLY IN THE CASE UPON CLEANING THE SCOPE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178236 VASOVIEW 6 PRO ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC VH-2400 25070241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA