BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2 EVH SYSTEM

    MDR report key: 2093277 · Received April 14, 2011

    Report

    Report Number
    2242352-2011-00282
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A VISUAL INSPECTION REVEALED THAT THE JAWS WERE VERY BURNT. THE HEATER HAD LIFTED UP SOMEWHAT IN THE CENTER AND WAS EXPOSED AT THE SILICONE TIP WHICH WAS SOMEWHAT TORN. THERE WAS SOME EVIDENCE OF BLOOD. THE DEVICE WAS TESTED FOR DEACTIVATION AFTER RELEASING THE TOGGLE. THE DEVICE DID NOT FULLY DEACTIVATE WHEN THE TOOL WAS IN THE CANNULA WITH THE SHAFT FLEXED AT AN ANGLE. RESISTANCE AND JAW FORCE MEASUREMENTS PASSED SPECIFICATIONS. A FUNCTIONAL TEST EVALUATING THE THERMAL SHUT-DOWN PERFORMANCE OF THE UNIT WAS PERFORMED ON THE RETURNED DEVICE USING A REFERENCE POWER SUPPLY AND CABLE. THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS DURING THE DEVICE ACTIVATION. BASED UPON THE OBSERVATION OF THE HEATER TIP DETACHED, THE REPORTED COMPLAINT FOR "METAL WIRE SEPARATED" 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 2 METAL WIRE SEPARATED FROM THE JAW DURING THE PROCEDURE. THIS OCCURRED HALFWAY THROUGH THE PROCEDURE, AND THE JAWS HAD NOT BEEN CLEANED YET. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO 2 EVH SYSTEM ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI MAQUET CARDIOVASCULAR, LLC VH-4000 25026277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA