BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLOGRIP III HANDPIECE

    MDR report key: 3165603 · Received June 12, 2013

    Report

    Report Number
    2950727-2013-00030
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    March 6, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CARDIOGENESIS CORPORATION
    Product Code
    MNO
    PMA / PMN Number
    P970029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURING RECORDS REVIEW WAS PERFORMED TO DETERMINE IF THERE WERE ISSUES DURING MANUFACTURING THAT COULD BE ATTRIBUTED TO THE REPORTED EVENT. THERE WERE NO ISSUES DURING MANUFACTURING NOTED IN THE DEVICE HISTORY RECORD FOR THE HANDPIECE. UPON VISUAL INSPECTION, THE FIBERS WERE OBSERVED TO HAVE BEEN SEVERED AT THE COUPLER. ADDITIONALLY, THE FIBERS APPEARED CHARRED WHERE THEY WERE SEVERED. THE OBSERVED DAMAGE IS INDICATIVE OF USER MISHANDLING. IT IS POSSIBLE THAT THE USER WAS PULLING THE HANDPIECE AND CAUSED THE FIBER TO SEVER. IT IS ALSO POSSIBLE THAT THE FIBER WAS BENT AT THIS LOCATION. WHEN THE LASER IS PULSED, EXTREME HEAT IS PRODUCED RESULTING IN CHARRING OF THE FIBER AND BREAKAGE OF THE FIBER BUNDLE IF THERE IS A SHARP BEND IN THE FIBER. THE INSTRUCTION FOR USE PROVIDE ADEQUATE INSTRUCTIONS ON PROPER OPTICAL FIBER HANDLING. 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 END OF THE FIBER WHICH DOES NOT CONTACT THE PATIENT.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT, THE END OF THE HANDPIECE TIP STARTED SPARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265025 SOLOGRIP III HANDPIECE TRANSMYOCARDIAL LASER REVACULARIZATION HANDPIECE MNO CARDIOGENESIS CORPORATION HP-SG3 TA-03803

    Patients

    Seq Age Sex Outcome Treatment
    1