BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2102244 · Received May 19, 2011

    Report

    Report Number
    2028159-2011-00564
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM BUT COULD NOT DUPLICATE THE PROBLEM REPORTED. THE FOOTSWITCH WAS REPLACED AND SENT FOR IN-HOUSE EVAL. PREVENTIVE MAINTENANCE WAS PERFORMED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. A VISUAL ASSESSMENT OF THE RETURNED FOOTSWITCH REVEALED A NONCONFORMING LEFT HEEL SWITCH. THE FOOTSWITCH WAS TESTED AND IT DID NOT PASS AS THE FOOTSWITCH WAS NONCONFORMING. ADD'L TESTING WAS PERFORMED AND IT DID NOT PASS TESTING DUE TO THE FACT THAT THE "FS UP" LED WOULD NOT TURN OFF WHEN THE TREADLE WAS IN THE FULL UP POSITION. THE FOOTSWITCH WAS THEN DISASSEMBLED, AND A VISUAL INSPECTION REVEALED THAT THE SWITCH PLATE WAS NONCONFORMING. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE WAS DETERMINED TO BE A NONCONFORMING SWITCH PLATE. AN INTERNAL INVESTIGATION WAS OPENED FOR A NONCONFORMING SWITCH PLATE ASSOCIATED WITH THE FOOTSWITCH. ALCON WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    A SURGICAL TECH REPORTED THE FOOTSWITCH STOPPED WORKING DURING SURGERY. THE SYSTEM WAS SWITCHED OUT AND THE SURGERY WAS COMPLETED FOLLOWING A 45 MINUTE DELAY. THERE WAS NO PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1