BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM

    MDR report key: 1182658 · Received September 25, 2008

    Report

    Report Number
    2953148-2008-00807
    Event Type
    Malfunction
    Date Received
    September 25, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    GUIDANT CORPORATION, CARDIAC SURGERY
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE INVESTIGATION WAS COMPLETED, AND THE RETURNED HEMOPRO DEVICE PERFORMED TO ELECTRICAL PRODUCT SPECIFICATION WHEN CONNECTED TO A REFERENCE EXTENSION CABLE AND POWER SUPPLY. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE RETURNED HEMOPRO AND CABLE WERE AGAIN CONNECTED TO A REFERENCE POWER SUPPLY AND THERE WAS NO POWER DELIVERED. THIS WAS A CLEAR INDICATION THAT THE CUSTOMER'S CABLE WAS DEFECTIVE AND THE HEMOPRO WAS FUNCTIONING CORRECTLY. CONTINUITY TESTS CONFIRMED THAT ONE OF THE WIRES IN THE CABLE APPEARED TO BE OPEN CIRCUIT (HIGH RESISTANCE). A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON CONFORMANCE REPORTS, WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEMOPRO WAS INITIALLY CONNECTED AND DEVICE SELF-ACTUATED AND WOULD NOT STOP DELIVERING ENERGY. DEVICE WAS UNPLUGGED AND RECONNECTED WITH THE SAME RESULT. THE HOSP USED A SECOND HEMOPRO DEVICE, SUCCESSFULLY COMPLETED THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM GEI GUIDANT CORPORATION, CARDIAC SURGERY VH-3000 8062471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA