BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 2003710 · Received February 23, 2011

    Report

    Report Number
    2242352-2011-00085
    Event Type
    Injury
    Date Received
    February 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE TIP OF THE COLD JAW BOOT HAD DETACHED AND WAS RECEIVED SEPARATELY. THE JAWS WERE SOMEWHAT BURNT. THERE WAS SOME EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "JAW BOOT BROKE OFF" WAS 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 HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE SILICON JAW BOOT BROKE OFF. THE PIECE WAS RETRIEVED WITH NO OTHER PATIENT EFFECTS REPORTED. A NEW KIT 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 25024926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other