MAUDE Adverse Event Report: NIDEK CO. LTD. YC-200 S PLUS; YAG LASER

Model Number YC-200

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

Nidek inc received a telephone call from the customer to report that they observed pitting lens when fired the laser for the first time.Focus shift setting was 250 posterior.The pitting lens happen last week, and the doctor informed the technician at the customer site to report pitting lens to nidek inc on (b)(6) 2022, and nidek inc received a telephone call on 05/09/2022.No injury was reported from the customer.Device evaluation is pending.Nidek inc.Considers pitting lens issue a reportable event as it is an undesirable condition and has the potential to cause or contribute to a serious injury if the issue were to recur.Technical background: the ophthalmic yag laser system yc-200 consists of a slit lamp and the yag laser and is indicated for the performance of posterior capsulotomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.This device uses passive q-switching for laser oscillation.With passive q-switching, the device first accumulates sufficient energy within the laser cavity then emits laser pulses of high peak power for extremely short durations by use of the q-switched optical element which changes between transparent and opaque according to the accumulation of energy.Yc-200 device is equipped with yag mode function only.Yc-200 s plus device is equipped with yag and slt mode functions.

Manufacturer Narrative

As of 05/19/2022, the device evaluation is pending.Nidek inc senior product marketing manager and senior sales & marketing manager are communicating with the user facility to schedule a visit.Follow-up mdr will be submitted once nidek inc receives further information from the user facility.

Event Description

Please see initial mdr submitted on 05/19/2022.

Manufacturer Narrative

Nidek inc.Determined that the cause of customer reported issue "pitting lens" was inconclusive.Nidek inc field service engineer (fse) powered on system and found in working order.Shot counter = 1,298.Measured 2.8mj at 3.0mj setting.Measured 4.7mj at 5.0mj setting.Optical breakdown = 1.5mj.Beam coincidence checked ok.Fse performed following service activities as preventive measures: o performed complete inspection of the laser system.O auto-calibration of the pfn voltage = 465vdc.O cleaned objective lens and oculars.O for good measure, calibrated laser energies: 0.3mj, 0.5mj, 1.0mj, 3.0mj, 5.0mj, 7.0mj, and 10.0mj in single, double, and triple burst modes.O verified: yag/aiming coincidence and offset focus shift is proper for 0 - 500 microns anterior and posterior.Yag energy output is in spec 0.2 - 10.0mj single burst, 0.4 - 20.0mj double burst, 0.6 - 30.0mj triple burst.Optical breakdown = 1.4mj.System operational at all settings and modes.All test shots and beam profile checked ok.The system was tested and inspected.Fse verified that the system is operational.The reported unit passed final inspection per inspection distribution acceptance record #idar-2021-0269, and installation and in-service training was performed properly per ins-2021-0144.There was no supporting evidence to point to machine, man, method/process and material as the cause of the reported complaint issue.As a precaution,rg-093-2 yc-200/ yc-200 s plus quick reference guide will be sent out to the customer to remind customer of safety information in yc-200 operator's manual to mitigate against potential occurrence of pitting lenses.Per device evaluation, fse verified that the system is operational.Based on the historical data review of 1 year, there are 6 related similar complaints but no device malfunction found, therefore no trend identified.Investigation is closed.

• Brand Name: YC-200 S PLUS
• Type of Device: YAG LASER
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer (Section G): NIDEK CO. LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• Manufacturer Contact: todd milholland ; 2040 corporate court; san jose, CA 95131 ; 4084686460
• MDR Report Key: 14459549
• MDR Text Key: 300379464
• Report Number: 0002936921-2022-00005
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 04987669101452
• UDI-Public: (01)04987669101452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: YC-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other