BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS

    MDR report key: 3983367 · Received July 7, 2014

    Report

    Report Number
    2028159-2014-01176
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). CODES PROVIDED BY MANUFACTURER. THIS REPORT WAS MAILED TO FDA ON: 07/09/2014. (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 PATIENT 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 SECOND OF TWO REPORTS FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394942 ACCURUS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1