BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2152371 · Received June 24, 2011

    Report

    Report Number
    2242352-2011-00696
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 1, 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
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE TIP OF THE COLD JAW SILICONE BOOT WAS DETACHED AND MISSING. THE JAWS WERE BURNT. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "JAW BOOT BROKE OFF" WAS CONFIRMED. THE LOT NUMBER COULD NOT BE OBTAINED SO A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VESSEL HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO DEVICE HAD THE JAWS FRACTURE INSIDE THE PATIENT'S LEG. IT WAS NOTICED TO BE CRACKED BEFORE IT ACTUALLY BROKE OFF. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO 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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA