BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III

    MDR report key: 2590433 · Received May 3, 2012

    Report

    Report Number
    2590433
    Event Type
    Malfunction
    Date Received
    May 3, 2012
    Date of Event
    May 2, 2012
    Report Date
    May 3, 2012
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN USING CARDIOGENESIS SOLOGRIP III HANDPIECE DELIVERY SYSTEM. WIRE ADJACENT TO HANDLE BURNED TWO HOLES IN PHYSICIAN'S GOWN AT HIS CHEST AREA. SUBSITUTED DEVICE WITH ANOTHER CARDIOGENESIS SOLOGRIP III HANDPIECE. PROCEDURE COMPLETED WITHOUT FURTHER INCIDENCE. NO UNTOWARD PATIENT EFFECTS. PHYSICIAN NOT INJURED. THE CALIBRATION FOR THIS DEVICE IS 47%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION MNO CARDIOGENESIS CORPORATION * TA-03733

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR