MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-10 for YC-1800 manufactured by Nidek Co., Ltd..
[5204636]
Nidek received a complaint from the customer on (b)(6) 2014. Customer reported that during the laser surgery with yc-1800; sn (b)(4) aiming beam was out of focus and there were 4 additional lights near the aiming beam. Customer also reported about seeing a red reflex in the posterior chamber.
Patient Sequence No: 1, Text Type: D, B5
[12670670]
The affected device was not returned to nidek for eval. However, a nidek field service engineer (fse) had conducted an on-site eval. The problem could not be duplicated on target card; however, fse did see a red reflection when testing through the ocular capsulotomy lens. Fse found oculars and internal diode lens plate dirty. Fse suggested that there could be a smearing of the ocular lens due to the eye lash or normal contact. However the internal lens plate could get smeared due to the dirt. Fse cleaned the oculars, internal and external optics. Fse performed the auto calibration. The treatment output energies were checked and were within specifications. Laser aiming beam focus and alignment were verified and were within specifications. Focus shift and focus points were checked and were within the specifications. The system has been evaluated and no failure was found. According to fse the poor focusing could be from the ocular contact lens being used or the pt's eye anatomy. Nidek made attempts to contact the customer to gather additional info regarding the reported event without success. If additional significant info is received at a later date, a follow-up report will be submitted. Nidek inc. Considers it a reportable event as the device has malfunctioned and has a potential to cause a serious injury if the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2014-00042 |
| MDR Report Key | 4349509 |
| Report Source | 05,06 |
| Date Received | 2014-12-10 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-11-05 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2014-12-30 |
| 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 |
| 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 | 2014-12-10 |
| 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, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-10 |