BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSAR LASER SYSTEM-FS 3D

    MDR report key: 5075512 · Received September 14, 2015

    Report

    Report Number
    3009026057-2015-00033
    Event Type
    Injury
    Date Received
    September 14, 2015
    Date of Event
    August 19, 2015
    Report Date
    September 14, 2015
    Manufacturer
    LENSAR, INC
    Product Code
    OOE
    PMA / PMN Number
    K120214
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL FILE WAS REVIEWED AND NOTED THAT THE RUN BUTTON WAS DEPRESSED 1.97 SECONDS PRIOR TO THE PHYSICIAN DEPRESSING THE FIRE BUTTON ON THE JOYSTICK. FRAME 2 WAS TAKEN 60 MILLISECONDS AFTER THE PHYSICIAN DEPRESSED THE FIRE BUTTON AND SHOWED THAT FLUID WAS ALREADY BEING LOST OUT OF THE PID SUCTION RING. FRAME 3 WAS TAKEN AT 0.5 SECONDS AND SHOWS THAT THE CORNEA WAS IMPACTED BY THE LASER FROM APPROXIMATELY THE 10 O'CLOCK POSITION TO THE 3 O'CLOCK POSITION. A REVIEW OF THE SYSTEM LOG FILE SHOWED THAT THE SYSTEM DETECTED AN IMAGE PROCESSING: WATER/TARGET LOSS DETECTED 3 SECONDS AFTER THE RUN BUTTON WAS TOUCHED. HENCE, THE SYSTEM STOPPED THE PROCEDURE IMMEDIATELY UPON DETECTING A WATER/TARGET LOSS WHICH IS CONSISTENT WITH THE SURGICAL IMAGES. THE EXPECTATION IS THAT THE SURGEON AND THE STAFF WILL BE MONITORING THE PROGRESS OF THE SURGERY AND INTERVENING WHEN THERE IS A CONCERN WITH THE PROGRESS OF THE SURGERY. ALL INDICATIONS DEMONSTRATE THE LASER WAS FIRING IN THE CORRECT POSITION. THE INITIAL DAILY TEST THAT WAS PERFORMED AT 7:50 AM SHOWED A CENTRATION ERROR OF 31 UM AND A Z ERROR OF 28 UM. IN ADDITION, THE FIELD SERVICE ENGINEER REPEATED THE DAILY TEST AT THE END OF THE DAY THAT SHOWED THE SYSTEM WAS STILL WELL WITHIN SPECIFICATION WITH A CENTRATION ERROR OF 26 UM AND A Z ERROR OF 29 UM. ROOT CAUSE: USER ERROR - IMPROPER DOCKING AND LOCKING OF PID.

    Additional Manufacturer Narrative · 1

    THE SURGICAL FILE WAS REVIEWED AND NOTED THAT THE RUN BUTTON WAS DEPRESSED 1.97 SECONDS PRIOR TO THE PHYSICIAN DEPRESSING THE FIRE BUTTON ON THE JOYSTICK. FRAME 2 WAS TAKEN 60 MILLISECONDS AFTER THE PHYSICIAN DEPRESSED THE FIRE BUTTON AND SHOWED THAT FLUID WAS ALREADY BEING LOST OUT OF THE PID SUCTION RING. FRAME 3 WAS TAKEN AT 0.5 SECONDS AND SHOWS THAT THE CORNEA WAS IMPACTED BY THE LASER FROM APPROXIMATELY THE 10 O'CLOCK POSITION TO THE 3 O'CLOCK POSITION. A REVIEW OF THE SYSTEM LOG FILE SHOWED THAT THE SYSTEM DETECTED AN IMAGE PROCESSING: WATER/TARGET LOSS DETECTED 3 SECONDS AFTER THE RUN BUTTON WAS TOUCHED. HENCE, THE SYSTEM STOPPED THE PROCEDURE IMMEDIATELY UPON DETECTING A WATER/TARGET LOSS WHICH IS CONSISTENT WITH THE SURGICAL IMAGES. THE EXPECTATION IS THAT THE SURGEON AND THE STAFF WILL BE MONITORING THE PROGRESS OF THE SURGERY AND INTERVENING WHEN THERE IS A CONCERN WITH THE PROGRESS OF THE SURGERY. ALL INDICATIONS DEMONSTRATE THE LASER WAS FIRING IN THE CORRECT POSITION. THE INITIAL DAILY TEST THAT WAS PERFORMED AT 7:50 AM SHOWED A CENTRATION ERROR OF 31 UM AND A Z ERROR OF 28 UM. IN ADDITION, THE FIELD SERVICE ENGINEER REPEATED THE DAILY TEST AT THE END OF THE DAY THAT SHOWED THE SYSTEM WAS STILL WELL WITHIN SPECIFICATION WITH A CENTRATION ERROR OF 26 UM AND A Z ERROR OF 29 UM. ROOT CAUSE: USER ERROR - IMPROPER DOCKING AND LOCKING OF PID

    Description of Event or Problem · 1

    A DISTRIBUTOR FSE REPORTED TO LENSAR ON 8/20/15 THAT DURING SURGERY ON (B)(6) 2015 THE DOCTOR EXPERIENCED A "SUCTION LOSS" ERROR DURING SURGERY. DURING PHACO SURGERY THE SURGEON COMMENTED THAT THERE APPEARED TO BE A HALF CIRCLE ETCHED ON THE CORNEA.

    Description of Event or Problem · 1

    A DISTRIBUTOR FSE REPORTED TO LENSAR ON 8/20/15 THAT DURING SURGERY ON (B)(6)2015 THE DOCTOR EXPERIENCED A "SUCTION LOSS" ERROR DURING SURGERY. DURING PHACO SURGERY THE SURGEON COMMENTED THAT THERE APPEARED TO BE A HALF CIRCLE ETCHED ON THE CORNEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608090 LENSAR LASER SYSTEM-FS 3D LENSAR LASER SYSTEM-FS 3D OOE LENSAR, INC 70-00005-001 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other