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

Model Number	YC-200
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	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nidek inc.Considers pitting lens issue on yag laser a reportable event as the yc-200 had malfunction and has a potential to cause or contribute to a serious injury if the malfunction were to recur.Nidek inc.Field service manager (fsm) went on the customer site to inspect and perform service activities on 12/21/2021.No issue observed on yc-200 s plus yag laser (b)(4).The root cause of the reported issue "pitting on iol" is inconclusive.As a preventive measure, foot switch (part no.17330-0012) was installed as an option to help prevent pitting of the iol during surgery.If the footswitch is used, no flinching / movement of the joystick while the trigger button is pressed.
Event or Problem Description
On december 17, 2021.Nidek inc customer service representative received an email from the customer to report that the doctors noticed some pitting on the iol during capsulotomy procedures.The issue occurred while using yc-200 s plus yag laser (b)(4) in the facility's laser room.Follow ups were made to the customer by ra/qa director and field service manager between the dates of 12/17-12/23/2021; no response received to confirm the date of occurrence.No injury to patients was reported.Laser was inspected/serviced in the field at the customer's office per nidek reference# (b)(4).
Additional Manufacturer Narrative
Nidek inc.Received additional information about date of occurrence from the customer on 01/19/2022.The customer stated that the pitting lens issue occurred on (b)(6) 2021.There were three incident at the customer site with same device yc-200 s plus s/n.(b)(6).Nidek inc.Considers pitting lens issue a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issues were to recur.As reported in the initial mdr report, nidek inc field service manager went on the customer site to inspect and perform service activities on 12/21/2021.No issue observed on the device.
Event or Problem Description
Please see initial mdr submitted on 01/11/2022.

• Brand Name: YC-200 S PLUS
• Common Device Name: 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: 13231239
• Report Number: 0002936921-2022-00001
• Device Sequence Number: 17325319
• Product Code: HQF
• UDI-Device Identifier: 04987669101452
• UDI-Public: (01)04987669101452
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Device Model Number: YC-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 12/17/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown