BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165590 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00024
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    October 2, 2012
    Report Date
    June 12, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE REPORT, THE SOLOGRIP III HANDPIECE BEGAN SMOKING DURING USE. A SECOND HANDPIECE WAS NOT REQUIRED. THE HOSPITAL REPORTED THAT THE LOT NUMBER OF THE HANDPIECE WAS LOST WHEN THE HANDPIECE WAS DISCARDED. AS SUCH, THE LOT NUMBER WAS NOT KNOWN. POSSIBLE LOT NUMBERS WERE DETERMINED THROUGH SHIPPING RECORDS. A REVIEW OF MANUFACTURING RECORDS WAS PERFORMED FOR THOSE LOTS AND ALL LOTS WERE MANUFACTURED ACCORDING TO SPECIFICATIONS. A CAUSE OF THE REPORTED FAILURE COULD NOT BE IDENTIFIED BECAUSE THE HANDPIECE WAS NOT RETURNED. HOWEVER, SIMILAR EVENTS HAVE BEEN DUE TO BENDING THE STRAIN RELIEF TUBING WHILE MOVING THE THUMBSLIDE, RESULTING IN RESTRICTION OF THE FIBER AND BUCKLING OF THE FIBER WITHIN IN THE HANDPIECE. AS A CORRECTIVE ACTION, AN ATTENTION LABEL IS NOW ADHERED TO THE DEVICE PACKAGING. THE LABEL PROVIDES ADDITIONAL HANDLING INSTRUCTION DESIGNED TO PREVENT A RECURRENCE OF THIS TYPE OF EVENT. AT THE TIME THE REPORT WAS RECEIVED, CARDIOGENESIS DID NOT BELIEVE THE EVENT MET THE REPORTING REQUIREMENTS OF 21 CFR 803. THE EVENT DID NOT INVOLVE INJURY TO THE PATIENT, USER, OR ANY OTHER INDIVIDUAL. FURTHERMORE, THE EVENT WAS CONSIDERED TO BE OF A NATURE SUCH THAT A RECURRENCE COULD NOT REASONABLY BE EXPECTED TO CAUSE INJURY OR DEATH BECAUSE THE MALFUNCTION WAS CONFINED TO THE HANDPIECE HOUSING WHICH DOES NOT CONTACT THE PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE SOLOGRIP III HANDPIECE BEGAN SMOKING DURING USE. A SECOND HANDPIECE WAS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266924 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVASCULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION 705-37020 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1