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

Device Problem Unexpected Therapeutic Results (1631)

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

Event Type  malfunction  

Manufacturer Narrative

Initial device evaluation was performed on (b)(6) 2021 by nidek inc field service engineer (fse) at customer site.Laser energy and focus were within specification.No problem found.The reported unit s/n.(b)(4) will be replaced with new unit s/n.(b)(4).The unit s/n.(b)(4) will be returned in-house for further investigation.Follow up mdr will be submitted once in-house evaluation is completed.

Event Description

On (b)(6) 2021, nidek inc customer service representative received a telephone call from the customer to report that the laser is taking more shots to get an opening, and also reporting that the doctor is pitting the iol.The issue occurred while using the yc-200 s plus device s/n.(b)(4) in the facility's laser room.According to the doctor: "when we do yag lasers, we focus the beam just a bit posterior to the iol.If the energy hits the lens directly, it will pit it.It has minimal if any impact on the patients vision and nothing is done or needs to be done.".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 Description

Please see the initial mdr submitted on 03-jun-2021.

Manufacturer Narrative

On 05/19/2021, nidek inc field service engineer (fse) went on the customer site.Fse test fired yag laser and found that the error message "please wait" comes up at random times no matter how fast the joystick button is pressed.Fse found laser energy within spec.1.0mj = 0.98mj.Fse tested laser center and focus and found them to be within spec.No adjustments were made to new laser.The reported unit s/n.(b)(6) was replaced with s/n.(b)(6).The reported unit s/n.(b)(6) was returned to nidek inc in-house for further inspection.On 06/25/2021, nidek inc lead engineering technician tested and inspected the system.Observed normal working condition.Confirmed variation of focal point, proper energy output 0.3mj ~ 10mj with burst 2 and 3 as well, proper burn pattern and plasma, and laser firing normally.The cause of customer's reported problem "takes more shots to get an opening.Also pitting iol." is inconclusive.The system is operational.

• Brand Name: YC-200
• Type of Device: YAG LASER
• Manufacturer (Section D): NIDEK CO. LTD.; 34-14 hiroishi; gamagori, aichi 443-0 038; JA 443-0038
• MDR Report Key: 11935696
• MDR Text Key: 268275867
• Report Number: 0002936921-2021-00002
• Device Sequence Number: 1
• Product Code: HQF
• UDI-Device Identifier: 04987669101452
• UDI-Public: (01)04987669101452
• Combination Product (y/n): N
• PMA/PMN Number: K203130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

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
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 05/17/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other