BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2093402 · Received April 12, 2011

    Report

    Report Number
    2242352-2011-00262
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE COLD JAW SILICONE BOOT WAS PEELING ALONG THE SIDES AND TOP. THE JAWS WERE BURNT. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "JAW BOOT CRACKED" 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 HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, TWO VASOVIEW HEMOPRO JAW BOOT BROKE. THE FIRST JAW BOOT FRACTURED DURING THE PROCEDURE, ABOUT 1/2 WAY THROUGH HARVESTING. THE SECOND JAW BOOT WAS SLIDING OFF SO THE HARVESTER SLID THE JAW BOOT BACK ON AND USED IT TO COMPLETE THE PROCEDURE. NOTHING DETACHED FROM THE JAWS. THE HOSP DID NOT REPORT ANY PT 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 25027856

    Patients

    Seq Age Sex Outcome Treatment
    1 NA