BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE DELIVERY SYSTEM

    MDR report key: 2082676 · Received April 29, 2011

    Report

    Report Number
    2082676
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 29, 2011
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGERY THE MD WAS USING THE SOLOGRIP III DELIVERY HANDPIECE. THE MD PERCEIVED THAT THE DEVICE MALFUNCTIONED. HE STATED THAT THERE WAS A STRANGE SMELL AND FLASH OF LIGHT EMITTING FROM THE PROBE. THE MD NOTICED THAT THE FIBER WAS HARD TO ADVANCE. AFTER MAKING 17 CHANNELS, THE MD NOTICED LIGHT AND SMOKE COMING FROM THE AREA AROUND THE FINGERSLIDE AND THE DEVICE WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLOGRIP III HANDPIECE DELIVERY SYSTEM TRANSMYOCARDIAL REVASCULARIZATION DEVICE MNO CARDIOGENESIS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR