BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YC-1800

    MDR report key: 8618016 · Received May 16, 2019

    Report

    Report Number
    0002936921-2019-00007
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 19, 2019
    Report Date
    July 18, 2019
    Manufacturer
    NIDEK CO. LTD.
    Product Code
    LXS
    UDI-DI
    04987669100073
    PMA / PMN Number
    K893987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE YAG LASER, YC-1800 DEVICE S/N (B)(4) WAS EVALUATED BY NIDEK INC. IN-HOUSE SERVICE ENGINEER (SE). SE FOUND THE POWER OUTPUT WAS NOT STABLE. NIDEK INC. DETERMINED THAT THE FAULTY LASER HEAD RESULTED IN UNSTABLE POWER OUTPUT. HENCE, THE LASER HEAD ASSEMBLY WAS REPLACED. THE LASER OUTPUT WAS VERIFIED TO BE IN SPECIFICATION, 0.3 MJ-11.5 MJ AFTER REPLACEMENT OF THE LASER HEAD. PFN (PULSED FORM NETWORK) VOLTAGE WAS CALIBRATED TO 375VDC. FOCUS AND ALIGNMENT OF YAG/AIMING BEAM COINCIDENCE WAS PERFORMED. OPTICAL BREAKDOWN AT 3.8 MJ WAS VERIFIED TO BE 100%. THE CUSTOMER REPORTED OTHER ISSUES WITH THE LASER AND NIDEK INC. ADDRESSED THEM AS FOLLOWS: ISSUE: AIMING BEAM OUT OF ALIGNMENT. SERVICE PERFORMED: THE AIMING BEAM WAS NOTICED TO BE SLIGHTLY OFF ALIGNMENT; BUT STILL IN THE CENTER DUE TO SLIGHT MECHANICAL DRIFT OF THE ROTATING MIRRORS. SE ADJUSTED THE ROTATING MIRRORS SO THAT AIMING BEAM IS IN THE CENTER. ISSUE: AIMING BEAM ALIGNMENT WITH LASER. A) FOCUS SHIFT AT 0 M NOT GETTING MOST ENERGY ON THE TARGET BECAUSE THE POWER OUTPUT WAS LOW. B) FOCUS SHIFT AT 125 M GET MOST ENERGY ON THE TARGET BUT THE AIMING BEAM DEPTH IS ANTERIOR THAN THE LASER BEAM DEPTH. SERVICE PERFORMED: THERE WASN'T MUCH INFORMATION GIVEN BY THE DOCTOR. THE SETTING FOR THE POWER OUTPUT WAS UNKNOWN. THE SYSTEM WAS TESTED AND THE POWER OUTPUT WAS LOW. THE POWER OUTPUT WAS SET AT 10 MJ BUT THE ACTUAL OUTPUT WAS ONLY AT 6 MJ. THE FAULTY LASER HEAD CAUSED THE PITTING LENS ISSUE. FAULTY LASER HEAD WAS REPLACED. ISSUE: POWER DISPLAY IS DROPPING; AT ENERGY LEVEL SETTING OF 9.4 MJ, THE ENERGY SOMETIMES WOULD DROP DOWN TO 7.9 MJ AND THEN RETURN TO 9.1 MJ. SERVICE PERFORMED: THIS PROBLEM WAS CAUSED BY THE FAULTY LASER HEAD. FAULTY LASER HEAD WAS REPLACED. ISSUE: DIFFICULT TO FOCUS ON POSTERIOR CAPSULE AS THE AIMING BEAM SEEMED ELONGATED. SERVICE PERFORMED: FOCUS SHIFT WAS ADJUSTED TO RESOLVE THIS ISSUE. IT WAS VERIFIED THAT THE TWO AIMING SPOTS CONVERGE INTO ONE SPOT. INITIAL DEVICE EVALUATION WAS PERFORMED ON 16-MAY-2019 AND THE DEVICE WAS HAND CARRIED TO THE CUSTOMER SITE. WHILE TESTING AT THE CUSTOMER SITE, THE CUSTOMER ADDITIONALLY REPORTED THAT THE TWO AIMING BEAM SPOTS OVERLAP WITH EACH OTHER. THE LASER BEAM WAS FOUND TO OVERLAP DUE TO REFLECTION WITH THE POLAROID PAPER. IT WAS DEMONSTRATED TO THE DOCTOR ON (B)(6) 2019 THAT WHILE ROTATING FROM VERTICAL TO HORIZONTAL ORIENTATION, THE AIMING BEAM OVERLAP WITH EACH OTHER DUE TO REFLECTION FROM THE POLAROID PAPER. THIS HOWEVER DOESN'T HAPPEN WITH REGULAR PAPER OR WHILE SETTING UP THE DEVICE IN PATIENT ENVIRONMENT. CUSTOMERS ARE RECOMMENDED TO USE THE METAL FOCUSING ROD TO SET THE FOCUS ON THE EYEPIECES BEFORE THE PROCEDURE. THE POLAROID PAPER IS RECOMMENDED TO BE USED FOR TESTING PURPOSE ONLY. IN CONCLUSION, NIDEK INC. HAS DETERMINED THAT THE PROBABLE CAUSE OF PITTING LENS WAS DUE TO LOW POWER OUTPUT FROM THE FAULTY LASER HEAD. THE DEVICE FUNCTIONS PROPERLY AT ALL SETTINGS AFTER THE LASER HEAD WAS REPLACED.

    Description of Event or Problem · 0

    PLEASE SEE THE INITIAL MDR SUBMITTED ON 16-MAY-2019.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DEVICE YC-1800 #Y1620029 WAS RECENTLY REPAIRED BY NIDEK INC. ON 4/12/2019. THE DOCTOR PERFORMED 10 PROCEDURES (B)(6) 2019, BUT OBSERVED 2 INCIDENTS OF PITTING LENS. THE DOCTOR IS CURRENTLY OPERATING LOANER DEVICE # Y1620097 AND HAS NO PROBLEM WITH THE DEVICE FUNCTIONALITY. AT THIS TIME, EVALUATION ON THE YAG LASER IS ON-GOING; A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE DEVICE EVALUATION AND REPAIR ARE COMPLETED.

    Description of Event or Problem · 1

    NIDEK INC. SALES MANAGER RECEIVED A TELEPHONE CALL FROM THE CUSTOMER ON (B)(6) 2019 TO REPORT THAT THEIR YAG LASER YC-1800 WAS MALFUNCTIONING. THE DOCTOR WAS NOTICING PITTING LENS AND WAS HAVING TROUBLE FOCUSING. NIDEK INC. SERVICE MANAGER SPOKE TO THE CUSTOMER ON (B)(6) 2019. BASED ON DOCTOR'S REMARKS, THE AIMING BEAM TO YAG LASER BEAM ALIGNMENT WAS OFF; THE YAG LASER BEAM FOCUSES 120 ¿M ANTERIOR WITH RESPECT TO THE AIMING BEAM. THE SURGERIES WERE COMPLETE EVENTUALLY BY SETTING THE YAG LASER WITH 250 ¿M FOCUS SHIFT POSTERIORLY AT ENERGY 1.4 MJ. THERE WERE TWO CASES OF PITTING LENS REPORTED, THEREBY, TWO INDIVIDUAL REPORTS WILL BE SUBMITTED. THIS REPORT IS SUBMITTED FOR A MALE PATIENT WITH MULTI FOCAL TYPE IOL ON THE LEFT EYE. HOWEVER, THERE WAS NO PATIENT INJURY REPORTED. 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 ISSUE WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409239 YC-1800 YAG LASER LXS NIDEK CO. LTD. YC-1800 04987669100073

    Patients

    Seq Age Sex Outcome Treatment
    1