BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1083919 · Received July 28, 2008

    Report

    Report Number
    2953148-2008-00701
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 8, 2008
    Manufacturer
    GUIDANT CARDIAC SURGERY
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE TO PURSUE THE DEVICE BEING RETURNED TO CARDIAC SURGERY FOR INVESTIGATION WITH THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE BISECTOR WOULD NOT CAUTERIZED. THE STAFF REPLACED THE CORD, BUT IT STILL WOULD NOT WORK. 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 7XB ENDOSCOPIC VESSEL HARVESTING SYSTEM GCJ GUIDANT CARDIAC SURGERY VH-3200 8043071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA