BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2080227 · Received April 7, 2011

    Report

    Report Number
    2242352-2011-00246
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE SHAFT WAS KINKED IN THE CTR. THERE WERE NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. A PRE-CAUTERY TEST WAS PERFORMED ON THE DEVICE WITH A REFERENCE POWER SUPPLY AND EXTENSION CABLE. THE DEVICE PASSED THE PRE-CAUTERY TEST, IT PRODUCED STEAM AND HEAT DURING SEVERAL ACTIVATIONS AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. BASED UPON THE FUNCTIONAL TEST AND VISUAL OBSERVATION, THE REPORTED FAILURE "JAWS CHARRED" 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 HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO JAW BOOT BECAME CHARRED AND "DISINTEGRATED". THE HARVESTER HAD ALREADY FINISHED HARVESTING ONE LEG WITH THE DEVICE. WHEN HE MOVED TO THE SECOND LEG, AND AFTER LIGATING A COUPLE MORE BRANCHES, HE NOTICED THAT THE JAWS APPEARED TO BE VERY CHARRED/DISINTEGRATED. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS. THE TM REPORTED THAT THIS MAY HAVE BEEN A RESULT OF USING THE HEMOPRO FOR AN EXTENDED PERIOD OF TIME. 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 25026803

    Patients

    Seq Age Sex Outcome Treatment
    1 NA