BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREPOINT

    MDR report key: 2802988 · Received October 19, 2012

    Report

    Report Number
    2028159-2012-01608
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQF
    PMA / PMN Number
    K062624
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EXAMINED THE SYSTEM AND REPLICATED THE CUSTOMER REPORTED EVENT. THE COMPANY REP REPORTED THAT LASER POWER OUTPUT FROM "PORT ONE IS 60% LOWER THAN PORT TWO". ADD'L INFO RECEIVED STATED THAT THEY WERE UNABLE TO REPAIR PORT ONE, DUE TO PARTS BEING UNAVAILABLE. THE SYSTEM WAS THEN TESTED AND FOUND PORT 2 TO MEET SPECIFICATIONS. THERE WAS NO SAMPLE 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 NOT INDICATE ANY ADD'L SIMILAR REPORTS FOR THIS SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED DURING PHOTOCOAGULATION, A LOSS OF POWER DURING LASER EMISSION WAS NOTED. POWER ON BOTH PORTS IS NOT THE SAME. THE COAGULATION ON THE FIRST PORT IS PERFORMED AT 200 MEGAWATTS, WHILE ON THE SECOND PORT IT IS ACHIEVED AT 100 MEGAWATTS. THE SURGEON FEELS HE HAS TO WORK ON HIGHER POWER LEVELS. THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUREPOINT LASER, OPHTHALMIC HQF ALCON - IRVINE TECHNOLOGY CENTER PUREPOINT NA

    Patients

    Seq Age Sex Outcome Treatment
    1