BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 200PS

    MDR report key: 1102023 · Received August 7, 2008

    Report

    Report Number
    2028159-2008-00285
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBE WILL BE SENT FOR IN HOUSE TESTING. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE COULD NOT INSERT THIS 23 GAUGE PROBE WHEN HE USED A NON-ALCON TROCAR AND CANNULA DURING SURGERY. THE PROBLEM WAS SOLVED AFTER REPLACING THE PROBE WITH ANOTHER ONE (FROM THE SAME LOT NUMBER). THE CUSTOMER STATED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 200PS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI