BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 600DS

    MDR report key: 3983368 · Received July 7, 2014

    Report

    Report Number
    2028159-2014-01177
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 9, 2014
    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
    RP
    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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPHTHALMIC SURGEON REPORTED THE UNIT COULD NOT MAINTAIN THE EYE'S PRESSURE DURING THE AIR FLUID EXCHANGE PORTION OF A PARS PLANA VITRECTOMY PROCEDURE. THE EYE COLLAPSED DURING AIR FLUID EXCHANGE AND WHEN REMOVING INSTRUMENTS FROM THE TROCAR CANNULA, WHEREIN THEY HAD TO COMPENSATE BY IMMEDIATELY PLUGGING AN OPEN PORT. THERE WAS NO PT HARM REPORTED. IN ADDITION TO THIS REPORT, IT WAS NOTED THAT THE AIR FLUID EXCHANGE TUBING USED WAS NOT NEW, AND WAS REUSED FROM A PREVIOUS PROCEDURE. THIS IS THE FIRST OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395057 ACCURUS 600DS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CTR ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1