BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1891082 · Received October 22, 2010

    Report

    Report Number
    2028159-2010-02057
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY CANCELLED THE SERVICE REQUEST. NO SAMPLES WERE RETURNED FOR EVAL. THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A CASE A SYSTEM MESSAGE WAS REC'D. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. ADD'L INFO, REC'D FROM THE NURSE, INDICATED THE ISSUE OCCURRED DURING SETUP. THE SYSTEM WAS REBOOTED BUT THE MESSAGE DID NOT CLEAR. THE UNIT WAS SWITCHED OUT WITH A 15 MINUTE DELAY TO THE START OF THE SURGERY. THERE WAS NO PT INJURY OR CANCELLATIONS 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