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

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 08/27/2021

Event Type  malfunction  

Manufacturer Narrative

On 09/02/2021, nidek inc field service engineer (fse) went to the customer site.The reported issue was not duplicated.Fse tested laser focus and focus shift, and found both within specification.Tested laser energy and found energy within specification.10mj=10mj.Tested laser slit illumination and found it within specification.The system is operational.The root cause of the issue is inconclusive.The reported issue was not duplicated.

Event Description

On (b)(6) 2021, nidek inc customer representative received an email from the customer to report that the doctor saw pitting on iol but pushed the laser forward to stop it from happening.The doctor reports that if focused behind the capsule with the aiming beams split, it does fine.The doctor informed nidek inc that the patient is fine, pitting was inferior to undilated pupil and will not interfere with vision.Patient will not have any adverse effects.Nidek inc considers this issue on yc-200 as a reportable event as an undesirable condition occurred while using the device.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.

• Brand Name: YC-200
• Type of Device: YAG LASER
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• MDR Report Key: 12465408
• MDR Text Key: 280684637
• Report Number: 0002936921-2021-00004
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 04987669101452
• UDI-Public: (01)04987669101452
• Combination Product (y/n): N
• PMA/PMN Number: K203130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other