BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2180686 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00816
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 12, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP HAD NO NON CONFORMITIES. THERE WAS NO EVIDENCE OF BLOOD. A FUNCTIONAL TEST WAS PERFORMED ON THE DEVICE. THE DISSECTION TIP WAS ABLE TO BE ASSEMBLED ONTO A REFERENCE ENDOSCOPE AND FIT PROPERLY. IT WAS NOT LOOSE. BASED UPON THIS, THE REPORTED COMPLAINT "DID NOT TIGHTEN" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO DISSECTION TIP WOULD NOT SCREW ON TO THE SCOPE. THE TIP CAUGHT ONTO THE SCOPE, BUT THE USER FELT IT DID NOT TIGHTEN ALL OF THE WAY, IT LOOKED LOOSE AND WOBBLY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3000 25032726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA