BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 2191359 · Received July 27, 2011

    Report

    Report Number
    2028159-2011-00860
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLACED THE 57 PSI PRESSURE REGULATOR AND THE L7 AND L8 SOLENOID ASSEMBLIES. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. THERE WERE NO SAMPLES 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. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT DURING A VITRECTOMY PROCEDURE, THE 23 GAUGE PROBE WAS NOT CUTTING BUT ASPIRATION CONTINUED. ADD'L INFO FROM THE NURSE INDICATED WHEN THE SURGEON PRESSED THE FOOT PEDAL, PRESSURE WAS LOST. THE CASE WAS COMPLETED USING A 20 GAUGE PROBE; HOWEVER, THE NURSE INDICATED THE PROBE SOUNDED "SICK" UNTIL THE SURGEON LOWERED THE CUT RATE. AS A RESULT, THE CASE WAS REPORTED AS BEING PROLONGED. THERE WAS NO HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1