BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2191933 · Received July 22, 2011

    Report

    Report Number
    2028159-2011-00844
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 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
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS ABLE TO REPLICATE THE CUSTOMER REPORTED EVENT. THE COMPANY REP ALSO OBSERVED FLUIDS WERE DRAINING SLOWLY AFTER SYSTEM MESSAGE "DRAINING CASSETTE - PLEASE WAIT" WAS RECEIVED, AND THAT SOMETIMES THE SYSTEM DRAINS PROPERLY AND OTHER TIMES IT DOESN'T. A REVIEW OF THE SYSTEM'S EVENT LOG WAS ABLE TO CONFIRM THE REPORTED EVENT OF INTERMITTENT ASPIRATION DURING VITRECTOMY MODE. SYSTEM MESSAGE "UNABLE TO ASPIRATE - PLEASE TURN ON INFUSION" WAS OBSERVED SEVERAL TIMES WHILE THE CUSTOMER WAS IN VITRECTOMY MODE. HOWEVER, IT IS UNCLEAR IF THIS SYSTEM MESSAGE WAS GENERATED WHILE INFUSION WAS ON OR INDUCED BY THE CUSTOMER BY HAVING INFUSION OFF AND ATTEMPTING TO USE THE VITRECTOMY FUNCTION. NO SAMPLE WAS RETURNED FOR EVAL AND NO ADD'L INFO PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID INDICATE 1 SIMILAR REPORT FOR THIS SYSTEM. THE ROOT CAUSE OF THE CUSTOMER REPORTED EVENT IS UNK. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT DURING SURGERY, THERE WERE INTERMITTENT DEFICIENCIES OF THE ASPIRATION WHILE IN VITRECTOMY MODE. THERE WAS A 30 MINUTE DELAY, AND THE SURGERY WAS COMPLETED WITH THE SAME EQUIPMENT. THERE WAS NO HARM TO THE PT.

    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 UNK