BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1812188 · Received August 17, 2010

    Report

    Report Number
    2242352-2010-02473
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(4), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE JAWS WERE BURNT, AND THE SILICON ON THE SIDE OF THE COLD JAW WAS PEELING. THERE WAS SOME EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "SILICON BOOT PEELED BACK" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFO IS OBTAINED. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, DURING BRANCH LIGATION, IT WAS NOTED THE SILICONE BOOT COVERING OF THE JAW TO THE VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM UNIT APPEARED TO PEEL BACK FROM THE TIP. NO PIECES BECAME DISLODGED IN THE PT, NO RETRIEVAL WAS REQUIRED, JUST REMOVAL OF THE DEVICE BEFORE THE SILICON BECAME COMPLETELY DISLODGED. THE DEVICE WAS REMOVED, ANOTHER VASOVIEW HEMOPRO VESSEL HARVESTING SYSTEM WAS OBTAINED AND THE CASE WAS COMPLETED SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PT. 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 25012023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA