BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 3832006 · Received March 7, 2014

    Report

    Report Number
    2242352-2014-00231
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICIAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORRD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE C RING ON THE VASOVIEW HEMOPRO WAS STUCK IN THE JAWS OF THE DEVICE. THE DEFECT WAS NOTICED AFTER THE DEVICE WAS PREPARED FOR SURGERY. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138992 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI