BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2043048 · Received March 25, 2011

    Report

    Report Number
    2028159-2011-00260
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVAL AND NO ADDITIONAL INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. THE ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED DURING A VITRECTOMY PROCEDURE, THE SYSTEM DID NOT PERFORM THE CUTTING ACTION WELL AND WOULD REFLUX INSTEAD OF ASPIRATING. ALL CONSUMABLES WERE EXCHANGED, AND THE SYSTEM WORKED BETTER BUT WAS SLOW OR SLUGGISH IN ITS ACTIONS. THERE WAS NO INJURY TO THE PT. THE SAME SYSTEM WAS USED TO COMPLETE THE PROCEDURE.

    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