BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LADARVISION 4000

    MDR report key: 1060136 · Received June 11, 2008

    Report

    Report Number
    1061857-2008-00076
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    November 9, 2006
    Report Date
    November 9, 2006
    Manufacturer
    ALCON - ORLANDO TECHNOLOGY CENTER
    Product Code
    LZS
    PMA / PMN Number
    P970043
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTING OF THIS COMPLAINT AT THIS TIME IS BASED ON RECEIPT OF A LETTER FROM THE FDA DATED 4/10/08 IN WHICH THE AGENCY INFORMED ALCON THAT COMPLAINT (EVENT DATE: 2006) SHOULD HAVE BEEN REPORTED AS A SERIOUS INJURY MDR. AS A RESULT OF THAT INJURY REPORT, A 2-YEAR REPORTING TIMEFRAME WAS INITIATED FOR ALL COMPLAINTS OF THE SAME TYPE. ALL COMPLAINT FILES FOR THE LADARVISION4000 WERE REVIEWED FOR THIS TYPE OF EVENT STARTING THE SAME DAY. THIS MDR FILING IS A RESULT OF THAT RETROSPECTIVE REVIEW. DETERMINATION OF ROOT CAUSE: ASSESSEMENT: THE FIELD SVC ENGINEER (FSE) WAS DISPATCHED TO THE SITE TO EVALUATE THE DEVICE. THE FSE FOUND A WORN BNC CONNECTOR ON THE DIGITIZER JOULEMETER. THE DIGITIZER JOULEMETER WAS REPLACED, THEN THE FSE PERFORMED A SYSTEM VERIFICATION PRIOR TO DEPARTURE. THE RETURNED PART WAS VISUALLY INSPECTED BY MFG AND THEN INSTALLED IN A TEST LASER SYSTEM. MULTIPLE SURGERY DAY PERFORMANCE TESTS AND TESTS SURGERIES WERE PERFORMED WHILE MONITORING FOR LASER NOT FIRING; HOWEVER, MFG WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. CONCLUSION: BASED ON THE INVESTIGATION OF THIS EVENT, THE ROOT CAUSE IS COMPONENT RELATED, SPECIFICALLY A FAULTY DIGITIZER JOULEMETER.

    Description of Event or Problem · 1

    A SYSTEM OPERATOR REPORTS THE LASER STOPPED FIRING DURING A PROCEDURE. THE SYSTEM OPERATOR HIT ABLATE AND THE SURGEON WAS ABLE TO COMPLETE THE SURGERY WITHOUT FURTHER INTERRUPTION. THE SYSTEM OPERATOR STATED THE SURGEON WAS SATISFIED WITH THE PT'S OUTCOME, AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LADARVISION 4000 OPHTHALMIC EXCIMER LASER SYSTEM LZS ALCON - ORLANDO TECHNOLOGY CENTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK