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 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

Nidek inc.Determined that the cause of customer reported issue pitting lens and low power was inconclusive.The reported issue pitting lens and low power was not duplicated.Nidek inc field service engineer (fse) tested laser focus and found that the treatment and aiming beams are parfocal.Tested the laser energy and found it within spec.10mj = 10mj.Laser shot count is 10660.The reported unit passed final inspection per inspection distribution acceptance record (ref# idar-2021-0351), and installation and in-service training was performed properly per installation in-service record (ref# ins-2021-0161).There was no supporting evidence to point to machine, man, and method/process and material as the cause of the reported complaint issue.As a precaution, split illumination tower was installed to allow more light when viewing capsule, and 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.Device evaluation is completed and fse verified that the system is operational.

Event Description

On (b)(6) 2022.Nidek inc.Customer service representative received an email from the customer to report that one doctor is pitting lens, he is using 1.2mj and a 275um offset, low energy, large offset, no error display on unit.No injury reported.On (b)(6) 2022.The device evaluation was completed at the customer site on 04/13/2022.Per customer service order #cso-2022-0278 by nidek inc field service engineer.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

This follow-up mdr 0002936921-2022-00003 adds "date of event".

Event Description

Please see initial mdr submitted on 05/03/2022.

• 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: 14283301
• MDR Text Key: 299573842
• Report Number: 0002936921-2022-00003
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: YC-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other