MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-11 for YC-1800 manufactured by Nidek Co., Ltd..
[5933717]
Nidek inc. Rec'd a complaint from a customer on (b)(6) 2015. Customer reported that during the use of yc-1800 sn (b)(4). Aiming beam was out of focus when the oculars were set at the lower magnification. Aiming beam was in focus when the oculars were set at a higher magnification but the capsule was not visible. However doctor wanted to use the magnification at a higher settings. Even though doctor could treat the pts without incident or any injury at this time he requested nidek to check the laser.
Patient Sequence No: 1, Text Type: D, B5
[13370455]
The affected device was not returned back to nidek. Nidek field svc engineer (fse) contacted the facility and phone support was provided. The issue was resolved over the phone. Fse verified the complaint over the phone. Fse confirmed with the tech that during installation of the binoculars tech pulled on the eye pieces which resulted the misalignment of the eye pieces and the binoculars and thus caused the aiming out of focus. Fse instructed tech to align the eyepieces and the issue was resolved over the phone. At this time no pt has been affected and hence no pt info is available. 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 of the malfunction were to recur.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00023 |
| MDR Report Key | 4844599 |
| Report Source | 05,06 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-05-15 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-05-15 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2015-07-09 |
| 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 | 2015-06-11 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-11 |