MAUDE Adverse Event Report: NIDEK CO. LTD. YC-200 S

Model Number YC-200

Device Problem Unexpected Therapeutic Results (1631)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, nidek inc.Sales manager received an email from a doctor reporting that he has pitted the lens on all 7 yag caps he has done so far with yc-200s s/n (b)(4).Per doctor, "all turned out subjectively as expected with happy patient outcomes.Remarkable iop reduction on slt." per doctor, the pitting lenses have occurred on the following dates: (b)(6) 2021, (b)(6) 2021, and (b)(6) 2022.Nidek inc.Considers pitting lens issue a reportable event as it is an undesirable condition and has a potential cause or contribute to a serious injury if the issues were to recur.Technical background: the ophthalmic yag laser system yc-200/ yc-200 s plus 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 device is equipped with yag and slt mode functions.

Manufacturer Narrative

Nidek inc.Determined the root cause of the pitting lenses as inconclusive.Nidek inc.Field service manager (fsm) provided servicing at customer's site on (b)(6) 2022 and concluded that the yag focus shift offset was found to be proper.Fsm checked the yc-200s system and the system started without issue.Shot counter was recorded (3,405); the console properly moves slowly in all directions.Settings: breath shield, oculars at 0,0, 12.5x magnification, 0.5mj, 125 microns posterior.The yag and slt aiming beams are focused properly with the slit illumination.The oculars and objective lens are clean.Fsm provided the following services: using laser zap paper, checked the anterior / posterior focus shift ablations, found them to be proper.Measured the yag output energy, found to be in proper specification.Cleaned the laser's axle and the joystick's pad.Removed left cover, inspected the focus shift drive motor and gear screws.Performed focus shift setting, per section 7.1.6 of the service manual.Calibrated 0.5mj, 1.0mj, and 3.0mj energy motor pulse settings.Fsm verified: the axle is properly aligned.Yag / slt energies are in proper specifications: yag: 0.3mj to 10.0mj, optical break down energy is 1.5mj.Slt: 0.3mj to 3.0mj using a micrometer jig, yag / aiming coincidence and offset focus shift are proper for 0 to 500 microns, anterior and posterior.Yag / aiming beams are properly aligned with the illumination slit beam.Slt / aiming beam coincidence is proper.System operation at all settings.The system was tested and inspected.System is operational.Since a device malfunction was not found, fsm went over the system's operation with dr.(b)(6).Fsm noted: "the suggested techniques for yag laser procedures were being followed and practiced by dr.(b)(6).Oculars are being set by the focus rod.Set the desired focus shift.Bring the aiming beams into focus, push forward, bring back into focus.Start at a low energy and increase until you see the desired tissue reaction.Demonstrated the focus shift reaction on laser zap paper and in a clear plastic target plate." the doctor had requested for a device exchange, therefore the decision was made for customer owned s/n (b)(4) to be exchanged with (b)(4).Installation of the new device has been completed on (b)(6) 2022 and the doctor was instructed again on the new device.Nidek inc.Will monitor use of the newly installed device.

• Brand Name: YC-200 S
• Type of Device: YC-200 S
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroishi; gamagori 443-0038, ja, ; JA
• Manufacturer (Section G): NIDEK CO. LTD.; 34-14 hiroishi; gamagori 443-0038, ja, ; JA
• Manufacturer Contact: todd milholland ; 2040 corporate court; san jose, CA 95131 ; 4084686460
• MDR Report Key: 13546068
• MDR Text Key: 285958846
• Report Number: 0002936921-2022-00002
• 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
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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