BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUIDANT VASO VIEW HEMOPRO

    MDR report key: 1070034 · Received July 3, 2008

    Report

    Report Number
    2953148-2008-00656
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 11, 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
    CA, 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 IS COMPLETED. (B) (4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO SUCCESSFULLY COMPLETED CAUTERIZING AND SEPARATING THE 3RD BRANCH. WHEN THE SURGEON COMPLETED THE 4TH BRANCH, HE DEACTIVATED THE DEVICE'S ACTIVATION TOGGLE SWITCH, BUT THE TISSUE WELDER WOULD NOT TURN OFF IN THE PT'S LEG AND THE POWER SUPPLY KEPT BEEPING. THE TISSUE WELDER'S JAWS BECAME READ AND BEGAN OVERHEATING. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDANT VASO VIEW HEMOPRO GEI GUIDANT CARDIAC SURGERY VH-3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA