BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 2100594 · Received May 13, 2011

    Report

    Report Number
    2028159-2011-00530
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 15, 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
    BR
    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

    A SURGEON REPORTED THAT THE EQUIPMENT DISPLAYED FULL CASSETTE EVEN THOUGH THE CASSETTE WAS NEW, AND THAT THE BATTERY RAN OUT WITH NO PREVIOUS WARNING DURING A VITRECTOMY PROCEDURE. THE CASE WAS CANCELLED AFTER THE PT HAD RECEIVED LOCAL ANESTHESIA. THERE WAS NO HARM OR INJURY TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 400VS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1