BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 1220413 · Received October 31, 2008

    Report

    Report Number
    2028159-2008-00393
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM, AND FOUND THAT IT MET SPECIFICATIONS. THE INTERIOR OF THE CONSOLE WAS INSPECTED AND THERE WERE NO SIGNS OF DAMAGE OR SMOKE. THE POWER SUPPLY WAS REPLACED AND THE CONSOLE WAS TESTED; ALL TESTING PASSED SPECIFICATIONS. IT WAS NOT POSSIBLE TO OBTAIN THE HANDPIECE USED DURING THE SURGERY AS IT HAD ALREADY BEEN SENT TO THE CENTRAL STERILIZATION UNIT. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WERE NO OTHER SIMILAR COMPLAINTS REPORTED FOR THIS SYSTEM. NO SAMPLES WERE RETURNED FOR FURTHER INVESTIGATION. THE HOSPITAL WAS CONDUCTING AN INTERNAL INVESTIGATION, AND DECLINED TO SEND IN THE POWER SUPPLY AT THIS TIME. THE ROOT CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING SURGERY, WITH THE PHACO HANDPIECE IN THE PATIENT'S EYE AND THE NUCLEUS ALREADY DIVIDED, THERE WAS A FLASH/ PUFF OF SMOKE AND BRIGHT LIGHT. A SYSTEM MESSAGE WAS DISPLAYED. THE FIRST PATIENT WAS TRANSFERRED TO ANOTHER FACILITY TO COMPLETE THE PROCEDURE. THIS PATIENT, IN PREPARATION FOR SURGERY, HAD RECEIVED A SUB-TENONS INJECTION OF AN ANTIBIOTIC AND STEROID, BUT WAS RETURNED TO THE WARD. THIS EVENT WAS REPORTED WITH MFG. REPORT # 2028159-2008-00343 ON 09/18/2008. NO PATIENT IDENTIFIERS WERE PROVIDED AT THE TIME OF THE FIRST REPORT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 600DS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI