BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 13014645 · Received December 15, 2021

    Report

    Report Number
    0002936921-2021-00005
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 2, 2021
    Report Date
    February 16, 2022
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    LXS
    UDI-DI
    04987669100073
    PMA / PMN Number
    K893987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NIDEK INC. FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AT CUSTOMER'S FACILITY ON 1/25/2022. IT WAS DETERMINED THAT THE CUSTOMER REPORTED "HITTING OF IOL INSTEAD OF CAPSULE" WAS INCONCLUSIVE. UPON INITIAL INSPECTION, FSE OBSERVED THE FOLLOWING ISSUES: ·THE OUTPUT ENERGY WAS FOUND TO BE SLIGHTLY LOW AT A SETTING OF 10.3MJ WITH ACTUAL ENERGY MEASURED AS 9.8MJ. ·ENERGY CONTROL WAS REMOVED AND FOUND IT TO BE DIRTY. ·CUSTOMER'S VOLK DOUBLE ASPHERIC CAPSULOTOMY LENS TO HAVE MANY SCRATCHES ON ITS SURFACE DUE TO CLEANING. TO RESOLVE THE LOW ENERGY OUTPUT WITH DIRTYING OF ENERGY CONTROL, CLEANING WAS DONE TO THE ENERGY CONTROL AND FOUND ENERGY CALIBRATION WITHIN SPECIFICATION 10MJ=10MJ. CLEANING WAS PROVIDED TO THE EYEPIECES AND OBJECTIVE LENS AS PART OF THE SERVICE ACTIVITY. THE LASER WAS THEN TESTED AND WAS VERIFIED AS OPERATIONAL. CUSTOMER HAD OWNED VOLK'S DOUBLE ASPHERIC CAPSULOTOMY LENS, AND HAD MANY SCRATCHES DUE TO CLEANING. THEREFORE, FSE RECOMMENDED REPLACEMENT OF THE CAPSULOTOMY LENS WITH A NEW ABRAHAM CAPSULOTOMY LENS. (BOTH CAPSULOTOMY LENSES ARE NOT SOLD BY NIDEK INC.) FSE NOTED, "ROOT CAUSE OF LASER HITTING IOL IS INCONCLUSIVE AND MAY BE DUE TO DIFFUSION OF YAG BEAM THROUGH CAPSULOTOMY LENS." THE REPORTED "AIMING BEAM SEEM TO BE OFF" MAY HAVE OCCURRED BY THE DIFFUSION OF THE YAG BEAM, WHICH HAVE BEEN CAUSED BY THE SCRATCHED LENS. HOWEVER, THIS COULD NOT BE DETERMINED AS THE DIRECT CAUSE OF "HITTING OF IOL". SLIGHTLY LOW ENERGY FROM YC-1800 COULD ALSO NOT BE DETERMINED AS THE DIRECT CAUSE OF THE "HITTING OF IOL. "

    Additional Manufacturer Narrative · 0

    NIDEK INC. CONSIDERS PITTING LENS ISSUE ON YAG LASER A REPORTABLE EVENT AS THE YC-1800 HAD MALFUNCTION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. AT THIS TIME, EVALUATION ON THE YAG LASER HAS NOT BEGUN, A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.

    Description of Event or Problem · 0

    PLEASE SEE INITIAL MDR SUBMITTED ON 12/15/2021.

    Description of Event or Problem · 0

    ON (B)(6) 2021, NIDEK INC. CUSTOMER SERVICE RECEIVED AN EMAIL FROM A DOCTOR ON THEIR YC-1800 S/N (B)(4): "I AM REACHING OUT TO TRY TO OBTAIN SERVICE ON THIS UNIT WE PURCHASED LAST YEAR. OUR SURGEON IS TELLING ME THAT THE AIMING BEAM SEEMS TO BE OFF. I THINK I UNDERSTAND THAT HE HAS HIS NORMAL POSTERIOR 250 SETTING ON, BUT LAST WEEK HE STARTED HITTING THE IOL INSTEAD OF THE CAPSULE WHEN AIMED AT THE CAPSULE." THE EVENT HAD OCCURED AT CUSTOMER'S FACILITY ON (B)(6) 2021. ACCORDING TO THE DOCTOR, THE FACILITY'S SURGEON REPORTS NO VISUALLY SIGNIFICANT ADVERSE EVENT, AND THE SURGEON DID REPORT MINIMAL OFF AXIS LENS PITTING FOR ONE PATIENT, BUT WAS ABLE TO COMPLETE THE PROCEDURE WITH IMPROVED VISION FOR THE PATIENT. NIDEK INC. CONSIDERS PITTING LENS ISSUE A REPORTABLE EVENT AS IT IS AN UNDESIRABLE CONDITION AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE ISSUES WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909710 YC-1800 YAG LASER LXS NIDEK CO. LTD. YC-1800 04987669100073

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other