BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2080116 · Received April 7, 2011

    Report

    Report Number
    2028159-2011-00332
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 8, 2011
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE PROBE WAS NOT WORKING CORRECTLY. ADD'L INFO RECEIVED INDICATED THE BIPOLAR BRUSH/HANDLE HEATED UP CAUSING "BUBBLING" IN THE EYE FLUID. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE INFO REGARDING IF THERE WAS ANY PT IMPACT BUT NO INFO HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1