BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2160813 · Received July 7, 2011

    Report

    Report Number
    2242352-2011-00930
    Event Type
    Injury
    Date Received
    July 7, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE C-RING HAD BEEN SPLIT IN HALF. THE OTHER HALF OF THE C-RING AND THE SCOPE WASH TUBING WERE RECEIVED SEPARATE. THE TUBING WAS INTACT. THE DEVICE WAS BLOODY. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "C-RING ARM BROKE OFF" 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 AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO C-RING ARM BROKE OFF INTO THE PATIENT'S LEG. THE PIECE WAS RETRIEVED THROUGH THE ORIGINAL INCISION. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. 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 25033953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other