MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-22 for YC-1800 manufactured by Nidek Co., Ltd.
[19306831]
Nidek inc received a complaint from a customer on (b)(6) 2015. Customer reported that during the use of yc-1800 sn: (b)(4) laser made a beeping sound and the resident doctor noticed that the displayed power had doubled. Doctor decreased power to what it was previously set and continued treating the pt. The procedure was completed and no injury was reported that time.
Patient Sequence No: 1, Text Type: D, B5
[19632603]
The affected device was not returned to nidek for eval. However, a nidek field service engineer (fse) had conducted an on-site eval. The device was evaluated and tested for proper function. Fse confirmed that the device has been functioning within specs. No problem was found. Fse identified that the doctor was using the energy control button to increase the power when he wanted to increase the power in small amount. (energy control: is used to set energy of the yag laser in the range from 0. 3 to 10. 0mj in 0. 1 mj increments. ) (reference: ophthalmic yag laser system yc-1800; operators manual; 3. System description, 13 energy control) fse explained to the doctor to use to joystick to increase the power in minor amounts i. E. 0. 2 mj. Nidek confirmed that there was no pt injury and the treatment was completed. Nidek inc considers it a reportable event as the device has malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00020 |
| MDR Report Key | 4795717 |
| Report Source | 05,06 |
| Date Received | 2015-05-22 |
| Date of Report | 2015-04-17 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-04-17 |
| Device Manufacturer Date | 2010-09-01 |
| Date Added to Maude | 2015-06-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DR |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5103537785 |
| 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 | 2015-05-22 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD |
| Manufacturer Address | 34-14 NIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-22 |