BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO EVH SYSTEM

    MDR report key: 1834432 · Received September 10, 2010

    Report

    Report Number
    2242352-2010-02745
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 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)(6), 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE SILICON COATING ON THE TIP OF THE COLD JAW BOOT WAS DETACHED AND WAS CRACKED AT THE BOTTOM OUTSIDE OF THE COLD JAW. THE JAWS WERE BURNT. THE DEVICE WAS BLOODY. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT FOR "BOOTS CRACKED/LOOSE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, DURING BRANCH LIGATION, THE JAWS OF THE VASOVIEW HEMOPRO BECAME DIRTY WITH TISSUE. UPON CLEANING AND INSPECTION OF THE JAWS, IT WAS NOTED THAT PART OF THE SILICON BOOT WAS CRACKED AND COMING LOOSE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT IS RETURNING.

    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 25016422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA