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

Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: YAG LASER
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• MDR Report Key: 12465408
• Report Number: 0002936921-2021-00004
• Device Sequence Number: 17160611
• Product Code: HQF
• UDI-Device Identifier: 04987669101452
• UDI-Public: (01)04987669101452
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K203130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other