MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-05-28 for YC-1800 YV-1800 manufactured by Nidek Co., Ltd..
[5891763]
Nidek inc received a complaint from a customer on (b)(6) 2015. Doctor complained that he noticed low power with yc-1800 sn (b)(4) during the surgery. Doctor explained that he had to fire more shots than usual and increase the power to complete the procedure. Doctor also mentioned due to this power issue one of his patient had a large floater.
Patient Sequence No: 1, Text Type: D, B5
[13413690]
The affected device was not returned to nidek for evaluation. However, a nidek field service engineer (fse) had conducted an on-site evaluation and the device was tested for proper operation. The treatment output energies were checked and were within specifications. Auto calibration was performed. On evaluation fse found that the illumination tower was straight in the center that was blocking the yag laser beam which has caused the low power. (reference: green laser photocoagulator model gyc-1000 combination delivery unit gyc2sz-3a operator's manual; s5 operating procedures; 5. 2 preparing for laser emission; 6 examine the patient's eye before the laser emission: caution). Fse instructed customer to move the light tower to left or right 10 degree from the center to avoid blocking of the laser beam. Nidek clinical specialist contacted customer to gather additional information regarding the complaint and confirmed that only one patient have been affected due to the issue. The patient was in the recovery phase at the time. Nidek considers this failure mode 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 | 3002807715-2015-00022 |
| MDR Report Key | 4808489 |
| Report Source | 05,06 |
| Date Received | 2015-05-28 |
| Date of Report | 2015-05-01 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-05-01 |
| Device Manufacturer Date | 2007-04-01 |
| Date Added to Maude | 2015-06-25 |
| 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 | 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 | 2015-05-28 |
| Model Number | YV-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, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-28 |