BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB

    MDR report key: 3111924 · Received May 7, 2013

    Report

    Report Number
    2242352-2013-00427
    Event Type
    Malfunction
    Date Received
    May 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVAL. 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 LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, ONE OF THE BLADES ON THE VASOVIEW 7 XB BROKE. 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
    200007 VASOVIEW 7 XB ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25066668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA