BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION VISION SYSTEM

    MDR report key: 6720745 · Received July 18, 2017

    Report

    Report Number
    2028159-2017-03061
    Event Type
    Malfunction
    Date Received
    July 18, 2017
    Date of Event
    June 21, 2017
    Report Date
    December 11, 2017
    Manufacturer
    ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K101285
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLICATED THE REPORTED EVENT. A FOOTSWITCH WAS RECEIVED AND A VISUAL ASSESSMENT OF THE RETURNED SAMPLE REVEALED REDDISH BROWN RESIDUE AROUND THE PRIMARY TREADLE SWITCH, CHARACTERISTIC OF BALANCED SALT SOLUTION (BSS) INGRESS AND CORROSION. THE PRIMARY TREADLE SWITCH WAS PRESSED AND FOUND TO STICK. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO CORROSION OF THE FOOTSWITCH FROM BSS INGRESS ON THE TREADLE CAUSING THE SWITCH TO STICK WHEN PRESSED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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).

    Additional Manufacturer Narrative · 1

    THE OPERATOR STOPPED THE LASER FROM FIRING BY TURNING THE KEY. THERE WAS NO PATIENT HARM. THE SYSTEM WAS EXAMINED, BUT THE COMPANY REPRESENTATIVE DID NOT MENTION IF THE REPORTED EVENT WAS REPLICATED. THE COMPANY REPRESENTATIVE FOUND RUST AND DAMAGE TO THE SCREWS CONNECTING THE FTS CABLE TO THE CONSOLE. THIS ISSUE WAS RESOLVED BY REPLACED THE AFFECTED COMPONENTS. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. A REVIEW OF THE CUSTOMER¿S COMPLAINT HISTORY FOR THE LAST 24 MONTHS DID NOT SHOW ANY PREVIOUS COMPLAINTS OF THIS KIND AGAINST THE SYSTEM. THE SYSTEM WAS MANUFACTURED ON APRIL 28, 2010. BASED ON QA ASSESSMENT, THE PRODUCT MET SPECIFICATIONS AT THE TIME OF RELEASE. THE SYSTEMS OPERATOR¿S MANUAL STATES: CARE AND MAINTENANCE: ¿DAMAGED HARDWARE MUST BE REPLACED TO ENSURE SAFE OPERATION.¿ THE ROOT CAUSE OF THE REPORTED EVENT AND THE OBSERVED DAMAGE AND RUST CANNOT BE DETERMINED CONCLUSIVELY. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 1

    A COMPLETED QUESTIONNAIRE WAS RECEIVED BY THE SURGEON. NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION WAS REQUIRED FOR THIS PATIENT.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL REPORTED THAT THE LASER DID NOT STOP DURING SURGERY. THE DOCTOR PRESSED THE FOOTSWITCH TO TREAT THE RETINA, THEN DECIDED TO STOP THE LASER TREATMENT BY REMOVING THE FOOT FROM THE FOOTSWITCH. THE LASER CONTINUED TO FIRE WHILE IN THE PATIENT'S EYE. THE LASER WAS TURNED OFF USING THE LASER KEY. THE LASER WAS RESTARTED AND THE CASE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501117 CONSTELLATION VISION SYSTEM UNIT, PHACOFRAGMENTATION HQC ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER TABLETOP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other