BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1221524 · Received November 5, 2008

    Report

    Report Number
    2953148-2008-00885
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 27, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE HOSPITAL DISCARDED THE PRODUCT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NON-CONFORMANCE WHICH COULD HAVE ATTRIBUTED TO THIS FAILURE MODE.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, WHEN THE SCRUB TECHNICIAN INSERTED THE HEMOPRO TISSUE WELDER INTO THE CANNULA, SHE FELT A "SNAP". SHE OBSERVED A CUT ON THE GREY TIP OF THE DEVICE WHEN SHE REMOVED THE TISSUE WELDER FROM THE CANNULA. THE TISSUE WELDER JAW BOOT CRACKING IS A REPORTABLE EVENT. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CARDIAC SURGERY VH-3000 8082871

    Patients

    Seq Age Sex Outcome Treatment
    1 NA