BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7 XB EVH SYSTEM

    MDR report key: 1931834 · Received November 30, 2010

    Report

    Report Number
    2242352-2010-03493
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K041981
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DISSECTION TIP WAS RECEIVED WITH THE CONICAL TIP DETACHED. THE TIP FORMED A COMPLETE ASSEMBLY. THERE WAS SOME ADHESIVE VISIBLE ON THE CONNECTING SURFACES. THERE WAS A VERTICAL CRACK ON THE INNER RIM OF THE JUICER. THERE WAS NO EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "CONICAL TIP BROKE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHILE THE HARVESTER WAS SCREWING THE CONICAL DISSECTION TIP ONTO THE SCOPE, IT BROKE INTO PIECES. THERE WAS NO PT CONTACT. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW 7 XB EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-3200 25020388

    Patients

    Seq Age Sex Outcome Treatment
    1 NA