BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2043289 · Received February 25, 2011

    Report

    Report Number
    2028159-2011-00175
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL BIOMED REPORTED THAT A SURGEON HAD THE TROCARS IN THE PT'S EYE AND HAD JUST COMPLETED AN INCISION TO PERFORM A VITRECTOMY WHEN THE CUTTER WAS TESTED AND IT WOULD NOT CUT. THE CUTTER WAS EXCHANGED AND THE SURGERY WAS COMPLETED THE SAME DAY WITH THE SAME SYSTEM. THE SURGERY WAS EXTENDED AN ADDITIONAL 30 MINUTES. THERE WAS NO PT INJURY OR HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK