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 12/15/2021

Event Type  malfunction  

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 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).

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 Description

Please see initial mdr submitted on 01/11/2022.

• 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: 13231239
• MDR Text Key: 286354419
• Report Number: 0002936921-2022-00001
• 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: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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; Hospitalization