BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSAR LASER SYSTEM - FS 3D

    MDR report key: 3140108 · Received May 29, 2013

    Report

    Report Number
    3009026057-2013-00003
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 21, 2013
    Manufacturer
    LENSAR INC
    Product Code
    OOE
    PMA / PMN Number
    K123859
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A LENSAR FSE REPORTED THAT DURING DOCTOR'S SURGERY TRAINING WHILE THE PHYSICIAN WAS DOCKING ON THE PT'S RIGHT EYE AND DURING THE PROCESS, THE DOCTOR SELECTED THE OPTION TO RELEASE THE PT THE PLATFORM DROVE TOWARD THE PT'S LEFT EYE AND THEN DISPLAYED A PLATFORM ELECTRICAL FAULT. THE BÖCKING PROCESS WAS NOT COMPLETED, NOR DID THE PID ARM TOUCH THE PT. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234827 LENSAR LASER SYSTEM - FS 3D LENSAR LASER SYSTEM - FS 3D OOE LENSAR INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK