MAUDE Adverse Event Report: NIDEK CO. LTD. YC-1800; YAG LASER

Model Number	YC-1800
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	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, nidek inc.Customer service received an email from a doctor on their yc-1800 s/n (b)(4): "i am reaching out to try to obtain service on this unit we purchased last year.Our surgeon is telling me that the aiming beam seems to be off.I think i understand that he has his normal posterior 250 setting on, but last week he started hitting the iol instead of the capsule when aimed at the capsule." the event had occured at customer's facility on (b)(6) 2021.According to the doctor, the facility's surgeon reports no visually significant adverse event, and the surgeon did report minimal off axis lens pitting for one patient, but was able to complete the procedure with improved vision for the patient.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.
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.
Additional Manufacturer Narrative
Nidek inc.Field service engineer (fse) evaluated the device at customer's facility on 1/25/2022.It was determined that the customer reported "hitting of iol instead of capsule" was inconclusive.Upon initial inspection, fse observed the following issues: ·the output energy was found to be slightly low at a setting of 10.3mj with actual energy measured as 9.8mj.·energy control was removed and found it to be dirty.·customer's volk double aspheric capsulotomy lens to have many scratches on its surface due to cleaning.To resolve the low energy output with dirtying of energy control, cleaning was done to the energy control and found energy calibration within specification 10mj=10mj.Cleaning was provided to the eyepieces and objective lens as part of the service activity.The laser was then tested and was verified as operational.Customer had owned volk's double aspheric capsulotomy lens, and had many scratches due to cleaning.Therefore, fse recommended replacement of the capsulotomy lens with a new abraham capsulotomy lens.(both capsulotomy lenses are not sold by nidek inc.) fse noted, "root cause of laser hitting iol is inconclusive and may be due to diffusion of yag beam through capsulotomy lens." the reported "aiming beam seem to be off" may have occurred by the diffusion of the yag beam, which have been caused by the scratched lens.However, this could not be determined as the direct cause of "hitting of iol".Slightly low energy from yc-1800 could also not be determined as the direct cause of the "hitting of iol.".
Event or Problem Description
Please see initial mdr submitted on 12/15/2021.

• Brand Name: YC-1800
• Common Device Name: YAG LASER
• 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
• Manufacturer Contact: todd milholland ; 2040 corporate court; san jose, CA 95131 ; 4084686460
• MDR Report Key: 13014645
• Report Number: 0002936921-2021-00005
• Device Sequence Number: 17305899
• Product Code: LXS
• UDI-Device Identifier: 04987669100073
• UDI-Public: (01)04987669100073
• Combination Product (Y/N): N
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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-1800
• 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: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2019
• 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
• Patient Sex: Unknown