BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3832383 · Received February 10, 2014

    Report

    Report Number
    2242352-2014-00086
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Report Date
    January 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A VISUAL INSPECTION DID NOT IDENTIFY ANY NON-CONFORMITIES. A FUNCTIONAL TEST WAS CONDUCTED ON THE DISSECTION TIP. THE DEVICE WAS ATTACHED TO A REFERENCE ENDOSCOPE AND VIEWED ON A MONITOR; VISIBILITY WAS NOT CLEAR THROUGH THE DISSECTION TIP, DISTORTION WAS OBSERVED. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. ADDITIONAL INFORMATION IS REQUIRED. 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 NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE DISSECTION TIP ON THE VASO VIEW HEMOPRO WAS CLOUDY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87601 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25089465

    Patients

    Seq Age Sex Outcome Treatment
    1 NI