BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2231167 · Received August 26, 2011

    Report

    Report Number
    2028159-2011-01028
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE EXAMINED THE SYSTEM AND WAS UNABLE TO REPLICATE THE REPORTED EVENT. THE SYSTEM WAS THEN TESTED AND MET PRODUCT SPECIFICATIONS. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, THE STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF THE SYSTEM'S EVENT LOG SHOWS THAT THE SYSTEM MESSAGE (SM) "RED STOP SIGN" OCCURRED ON (B)(4), 2011. THE USER WAS PERFORMING THE FLUID/AIR EXCHANGE (FAX) SLEW DOWN PROCESS WHEN THE MESSAGE APPEARED. AS A RISK MITIGATION MEASURE, THE SYSTEM GENERATES A MESSAGE REQUIRING THE SYSTEM TO BE RESET. DURING THIS PROCESS, THE SYSTEM PROVIDES BACK-UP INFUSION OF BSS AT 30 MMHG TO MAINTAIN EYE PRESSURE DURING THE PROCESS, WHICH IS THE DEFAULT INFUSION/IRRIGATION SAFE STATE. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS SYSTEM. BASED UPON A REVIEW OF THE EVENT LOG, THE ROOT CAUSE FOR THE REPORTED SM (RED STOP SIGN) WAS RAPID, MULTIPLE CLICKS ON THE FOOTSWITCH BUTTONS MAPPED TO "SLEW COMMANDS". THIS SM WAS DISPLAYED WHEN THE SYSTEM WAS UNABLE TO RESOLVE THE COMMANDS PROVIDED THROUGH THE FOOTSWITCH. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. 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 CUSTOMER REPORTED THAT THE SYSTEM STOPPED WORKING DURING SURGERY. THE EVENT OCCURRED DURING A PLANNED VITREORETINAL PROCEDURE TO TREAT A DETACHED RETINA. THE PT'S EYE COLLAPSED AND THE SURGEON MANUALLY "INFLATED" THE EYE. ADDITIONAL INFORMATION WAS RECEIVED FORM THE SURGEON INDICATING THE EVENT RESOLVED WITHOUT TREATMENT. THE PROCEDURE COMPLETED WAS A VITRECTOMY, CRYOPEXY AND GAS TO REPAIR A PREEXISTING RETINAL DETACHMENT.

    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 Required Intervention