MAUDE Adverse Event Report: YC-1800; YAG LASER

Model Number	YC-1800
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nidek inc.Considers pitting lens issue on yag laser a reportable event as the yc-1800 had malfunction and has a potential to cause or contribute to a serious injury if the malfunction were to recur.At this time, evaluation on the yag laser has not begun, a supplemental follow-up report will be submitted once the device evaluation and repair are completed.
Event or Problem Description
On (b)(6) 2021, nidek inc.Customer service received an email from a doctor to report that he is feeling like the depth is off on the aiming beam.He's not getting the "takes" on the laser when he should be (meaning there is no tissue response to the laser emission), and he also reports getting pitting when it should not be occurring.The issue occurred while using the yc-1800 device s/n (b)(4) in the facility's laser room.According to the doctor, the pitting lens occurred on (b)(4) 2021, but he had occasional pitting since he started using the laser in (b)(6) 2020.The current condition of the patient is fine, and he is pending follow-up in a couple of weeks.Per doctor, pitting lens did not result in permanent impairment of a body function or permanent damage to body structure.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.
Event or Problem Description
Please see the initial mdr submitted on 29-apr-2021.
Additional Manufacturer Narrative
The yag laser, yc-1800 device s/n (b)(6) was evaluated by a nidek inc.Field service engineer (fse) on 5/26/2021.Nidek inc.Determined that the pitting of iol was inconclusive.When fse tested the laser focus, the yag beam was par-focal with the aiming beam focus.Energy was measured at 10mj and the actual output was 9.5mj, which is within specification.Fse advised the doctor to try using the focus shift starting at posterior 250 offset and that the energy calibration being slightly off may have been a factor.As requested from the customer, fse performed preventive maintenance.With testing and inspection, customer's device was verified as operational.Nidek inc.Customer service followed up with the doctor on 5/28/2021.Per dr.(b)(6) , "vision is improved subjectively and objectively.The lens pitting is asymptomatic.Patient is doing well at 1 month follow up.".

• Brand Name: YC-1800
• Common Device Name: YAG LASER
• MDR Report Key: 11748164
• Report Number: 0002936921-2021-00001
• Device Sequence Number: 3224530
• Product Code: LXS
• UDI-Device Identifier: 04987669100073
• UDI-Public: (01)04987669100073
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K893987
• 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 faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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
• Device Model Number: YC-1800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2017
• 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