BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 400VS

    MDR report key: 696563 · Received October 13, 2005

    Report

    Report Number
    2028159-2005-00173
    Event Type
    Malfunction
    Date Received
    October 13, 2005
    Date of Event
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    H-10: RECEIVED PRESSURE VACUUM MANIFOLD (PVM) AND RECEIVER MECHANISM (RM) FOR EVALUATION. FOUND SIGNIFICANT FLUID INGRESS IN PVM; CAUSE UNKNOWN. RM ERROR CODE (PINCHER ERROR) DUE TO BROKEN WIRE ON SENSOR THAT DETECTS POSITION PINCHER. IT'S NOT POSSIBLE TO DETERMINE A LINK BETWEEN THESE TWO CONDITIONS. IT'S PROBABLE THAT FLUID INGRESS AND/OR BROKEN WIRE CAUSED PERFORMANCE PROBLEM REPORTED. ADDED H-6 METHOD CODE. THIS REPORT MAILED IN TO FDA ON: 11/11/2005 THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: IA051145-1

    Description of Event or Problem · 1

    REPORTER NOTED SYSTEM LOCKED UP DURING A CASE; ABORTED CASE. CLOSED EYE; PT WAS RESCHEDULED. STATED THERE WAS NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO