BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3111576 · Received May 6, 2013

    Report

    Report Number
    2242352-2013-00417
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORD IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C-RING FAILED TO RETRACT BACK INTO THE CANNULA AS IT WAS PARTIALLY DETACHED. NOTHING FELL INTO THE PATIENT AND NO INTERVENTION WAS REQUIRED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195990 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25069124

    Patients

    Seq Age Sex Outcome Treatment
    1 NA