BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1961056 · Received January 11, 2011

    Report

    Report Number
    2242352-2010-03949
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    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
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE TISSUE WELDER WAS RECEIVED INSIDE THE CANNULA. THE JAWS WERE BURNT AND THE SILICON ON THE TOP OF THE COLD BOOT TIP HAD DETACHED AND WAS PEELING. THE DEVICES WERE VERY BLOODY. A FUNCTIONAL TEST WAS PERFORMED SLIDING THE C-RING IN AND OUT WITH THE TOOL INSIDE THE CANNULA, AND SLIDING THE TOOL IN AND OUT OF THE CANNULA. THE C-RING DID NOT POP OUT, AND THE DEVICE PERFORMED AS EXPECTED. THEREFORE, THE COMPLAINT FOR "C-RING POPPED OUT AND CRACKED" COULD NOT BE REPRODUCED OR CONFIRMED. BASED UPON THE VISUAL OBSERVATIONS, A SECONDARY OBSERVATION OF "THE JAW BOOT INSULATION BROKE OFF" WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AT THE END OF AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE TOOL WAS CATCHING ON THE C-RING. THE C-RING KEPT POPPING OUT, CRACKED, AND BROKE OFF INSIDE THE PATIENT'S LEG. THE PIECE WAS RETRIEVED THROUGH THE ORIGINAL INCISION WITH NO OTHER PATIENT EFFECTS REPORTED. THE REPORTED 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 25021612

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other