BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2201135 · Received July 29, 2011

    Report

    Report Number
    2028159-2011-00878
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CTR
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND NOTED THE LEFT HEEL PADDLE DEFECTIVE ON THE FOOTSWITCH. NO OTHER PROBLEMS WERE FOUND. THE SYSTEM WAS TESTED AND MET ALL SPECS WITH EXCEPTION OF THE "FOOTSWITCH POSITIONS" TEST. THE CUSTOMER ORDERED A REPLACEMENT FOOTSWITCH. THE ROOT CAUSE IS UNK AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A SYSTEM MESSAGE DISPLAYED WHEN CHANGING FROM VIT MODE TO EXTRUSION MODE. THE FOOTSWITCH DISPLAY WAS THEN NOTICED LIT AS IF THE FOOT PEDAL WAS DEPRESSED; HOWEVER, THE SURGEON'S FOOT WAS NOT ON THE PEDAL. THE PT'S EYE WAS STABILIZED, THE SYSTEM'S CONNECTIONS WERE CHECKED, AND THEN THE SYSTEM WAS RECYCLED. AFTER THREE ATTEMPTS TO PRIME THE SYSTEM, AN ALTERNATE SYSTEM WAS USED TO COMPLETE THE CASE FOLLOWING A 20 TO 30 MINUTE DELAY. THERE WAS NO INJURY OR HARM TO THE PT. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CTR CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR