BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS HIGH BRIGHTNESS ILLUMINATOR

    MDR report key: 853390 · Received May 16, 2007

    Report

    Report Number
    2523835-2007-00015
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    January 9, 2007
    Report Date
    January 10, 2007
    Manufacturer
    ALCON PRECISION DEVICE - SINKING SPRING
    Product Code
    MPA
    PMA / PMN Number
    K951627
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ILLUMINATION PROBE WAS RECEIVED FOR EVALUATION. THE PROBLEM WAS CONFIRMED, AND THE CAUSE OF THE REPORTED PROBLEM IS A RETRACTED AND DISTORTED FIBER IN THE CANNULA. THE ROOT CAUSE OF THE CONFIRMED NONCONFORMITY OF DISTORTION WAS A RESULT OF HEAT ON THE FIBER TIP. THE NONCONFORMITY CAN OCCUR WHEN A PLASTIC FIBER ILLUMINATION PROBE IS IN AIR, THE FIBER TIP IS OCCLUDED, AND THE ILLUMINATION SOURCE THE PROBE IS CONNECTED TO IS SET TO A HIGH OUTPUT LEVEL. THIS REPORT MAILED IN TO FDA ON: 05/16/2007.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED A LOSS OF INTENSITY DURING CASE. THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS EXPECTED. THE EVALUATION, COMPLETED ON 04/16/2007, DISCOVERED A RETRACTED AND DISTORTED FIBER IN THE CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS HIGH BRIGHTNESS ILLUMINATOR ENDOILLUMINATOR MPA ALCON PRECISION DEVICE - SINKING SPRING AHBI NA

    Patients

    Seq Age Sex Outcome Treatment
    1