MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-30 for YC-1800 manufactured by Nidek Co., Ltd.
[136987223]
The device was evaluated by nidek service engineer (se) on 01/25/2019. Device was returned to nidek inc. For service since the customer reported of the laser not firing correctly. Se tested the device for proper operation. The laser wouldn't fire constantly. Every time the yag laser beam is emitted, an electrical beep sounds and plasma discharge occurs. An air plasma discharge occurs in 8 out of 10 firings at a standard of 5 mj or less. Se observed the laser would not fire constantly and plasma discharge occurred intermittently. Se found that the actual energy output was high; 13. 5mj. Calibration was out of specifications for yag laser beam. Hence, se calibrated the system for yag laser beam maximum energy output as described in the service manual section 7. 6. 1 maximum energy output. Then laser output was verified to be within specifications: 0. 2mj-11. 5mj. The customer reported issue was due to the device out of calibration. Device was tested and verified for proper operation. Additionally, the chin-rest grip was broken and missing two chin-rest pins. However, the parts were not replaced based on customer's decision. The device was last serviced in 9 september 2018 for routine preventive maintenance. The preset data and output display calibration was performed. The energies were within specification: 1. 0mj-10. 5 mj. Per operators manual it is recommended to perform calibration of power output of the yag laser once a year. Reference: 2. 4 after use, maintenance, and checks; caution, "to ensure the continued safe use of the device, the manager of the device must make sure that maintenance, preventive inspection, and laser output calibration are performed at least once a year. "
Patient Sequence No: 1, Text Type: N, H10
[136987224]
Nidek inc. Received a complaint from customer on (b)(6) 2018 reporting that during the use of yc-1800 sn: (b)(4); every 2nd to 3rd time the laser is fired, it sounds like it's firing, but not firing. High energy was identified during the device evaluation by nidek inc. Service engineer (se) on 01/25/2019. No injury was reported at that time and hence no patient information is available. Nidek inc. Considers high energy issue a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the issue to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2019-00003 |
| MDR Report Key | 8291219 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-30 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-25 |
| Date Mfgr Received | 2019-01-25 |
| Device Manufacturer Date | 2010-09-09 |
| Date Added to Maude | 2019-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOSHIO MURATA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 8002239044 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | GAMAGORI, AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | ND: YAG LASER |
| Product Code | LXS |
| Date Received | 2019-01-30 |
| Returned To Mfg | 2019-01-16 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-30 |