BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 2960449 · Received January 25, 2013

    Report

    Report Number
    2242352-2013-00015
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2012
    Report Date
    January 4, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 EVAL IS COMPLETED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE PRODUCT LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TIP OF THE HEMOPRO JAWS OVERHEATED. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35464 VASO VIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING GEI MAQUET CARDIOVASCULAR, LLC VH-3000 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA