BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 KB

    MDR report key: 2155243 · Received July 1, 2011

    Report

    Report Number
    2242352-2010-01289
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    April 2, 2010
    Report Date
    April 2, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THERE WERE NO NON CONFORMITIES WITH THE CANNULA AND IT WAS VERY BLOODY. A FUNCTIONAL LEAK TEST WAS PERFORMED WITH A SYRINGE AND THE DEVICE DID NOT WORK AS EXPECTED. BASED UPON THIS, THE REPORTED COMPLAINT WAS CONFIRMED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VH-3200 C-RING SLIDER WAS BENT. IT WAS DIFFICULT TO IRRIGATE THE SCOPE. THE IRRIGATION FROM THE C-RING WOULD SQUIRT STRAIGHT AND THEREFORE, JUST FLOODED THE FIELD WITH FLUID. AFTER ATTEMPTING TO USE THE DEVICE, A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 KB ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR VH-3200 25004271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA