BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHACO MACHINE BIOTRONIX

    MDR report key: 1202338 · Received October 15, 2008

    Report

    Report Number
    MW5008645
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ALCON LABORATORIES
    Product Code
    HQC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CATARACT SURGERY, THE ULTRASONIC HANDPIECE BECAME CLOGGED. THE ORT WAS UNABLE TO CLEAR THE ORIFICE AND TROUBLESHOOTING STEPS WERE UNSUCCESSFUL. ALL DEVICES, INCLUDING DISPOSABLE DEVICES AND THE INFINITY MACHINE X3 WERE CHANGED WITH NO SUCCESS. THE SALES REP WAS CALLED FOR STAT TECHNICAL ASSISTANCE. HE SUGGESTED THE SAME TROUBLESHOOTING STEPS THAT HAD BEEN IMPLEMENTED. ON THE 4TH, ATTEMPT TO CORRECT THE PROBLEM, THE ULTRASOUND MACHINE FUNCTIONED PROPERLY. DR WAS THEN ABLE TO COMPLETE THE PROCEDURE. THE ALCON SALES REP CAME TO THE SURGERY CENTER AND WE CHECKED EACH INFINITY MACHINE X3 AND VERIFIED THAT THE SETTINGS WERE CORRECT AND THAT THE DISPOSABLES WERE FUNCTIONING. NO PROBLEMS COULD BE REDUPLICATED. I REQUESTED THAT THE SALES REPRESENTATIVE BE PRESENT FOR DR'S CASES NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHACO MACHINE BIOTRONIX ULTRASONIC HANDPIECE HQC ALCON LABORATORIES INFINITY 0126861
    2 PHACO MACHINE BIOTRONIX ULTRASONIC HANDPIECE HQC ALCON LABORATORIES INFINITY 0126862
    3 PHACO MACHINE BIOTRONIX ULTRASONIC HANDPIECE HQC ALCON LABORATORIES INFINITY 0126864

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR