BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 20000 LEGACY

    MDR report key: 2201090 · Received July 29, 2011

    Report

    Report Number
    2028159-2011-00881
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 29, 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
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED VITRECTOMY ISSUE. HOWEVER, A CLEANING PAK FOR THE FLUIDICS MODULE WAS INSTALLED TO ADDRESS THE ASPIRATION EVENT. A "BAD CONTACT" WAS IDENTIFIED ON THE CAUTERY PCB (PRINTED CIRCUIT BOARD) AND REPAIRED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. NO SAMPLES RETURNED FOR EVALUATION. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING SURGERY, THERE WERE ISSUES WITH THE ASPIRATION, CAUTERY, AND VITRECTOMY. THE SYSTEM WAS EXCHANGED AND THE SURGERY WAS COMPLETED. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 20000 LEGACY PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER STTL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK