BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATALYS PRECISION LASER SYSTEM

    MDR report key: 4102302 · Received August 27, 2014

    Report

    Report Number
    3005675890-2014-00028
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 27, 2014
    Manufacturer
    OPTIMEDICA CORPORATION
    Product Code
    OOE
    PMA / PMN Number
    K121091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM DATABASE, SYSTEM OPTICAL COHERENCE TOMOGRAPHY (OCT) RECORDING, SYSTEM VIDEO DISPLAY RECORDING, AND THE OPERATION ROOM SURGICAL VIDEO WERE NOT AVAILABLE BECAUSE THE EVENT OCCURRED PRIOR TO DOCKING THE PATIENT TO THE SYSTEM. THE SURGEON REPORTED THAT THE INCIDENT OCCURRED WHEN A LARGE FRAIL PATIENT WAS SEATED SIDEWAYS ON THE PATIENT CHAIR AND THE MOTORIZED SEATBACK, WHICH HAS THE ARMREST ATTACHED TO IT, WAS MANUALLY RAISED FROM A SUPINE POSITION SO IT COULD THEN BE USED TO LOWER THE PATIENT GENTLY BACK DOWN INTO THE SUPINE POSITION. THE PATIENT CHAIR IS DESIGNED TO BE IN THE FULL UPRIGHT POSITION PRIOR TO LOADING THE PATIENT. THE SYSTEM PATIENT CHAIR PERFORMED AS DESIGN, HOWEVER, IT WAS USED IN A MANNER NOT INTENDED DUE TO INADEQUATE WARNINGS. USING THE CHAIR IN ANY CONFIGURATION OR POSITION OTHER THAN THE CONFIGURATIONS SPECIFICALLY RECOMMENDED IN THE OPERATOR MANUAL CONSTITUTES AN IMPROPER USE OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARMREST OF THE PATIENT CHAIR FOR THE CATALYS SYSTEM (SYSTEM) BEGAN TO PRESS DOWN ON THE PATIENT'S LEG AND CAUSE DISCOMFORT AS THE CHAIR'S MOTORIZED SEATBACK WAS MANUALLY RAISED FROM A SUPINE POSITION IN THE OPERATING ROOM (OR) PRIOR TO THE SURGICAL PROCEDURE TO REMOVE THE CATARACT. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522688 CATALYS PRECISION LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE OPTIMEDICA CORPORATION CATALYS-I

    Patients

    Seq Age Sex Outcome Treatment
    1