MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,oth report with the FDA on 2015-06-26 for YC-1800 manufactured by Nidek Co., Ltd.
[6261581]
Nidek inc received a complaint from a customer on (b)(6) 2015. Doctor reported that he has observed pitting lens during the treatment with yc-1800 (b)(4). Doctor complaint that during the surgery the aminging beam was out of focus and he had to increase the number os laser shots to complete the treatment. The surgery has been completed successfully and no pt injury was reported at this time.
Patient Sequence No: 1, Text Type: D, B5
[13304534]
The affected device has not been returned to nidek. The inspection has not done yet so the results of eval are not available. Nidek clinical specialist contacted doctor to gather add'l info regarding the complaint. Doctor reported that during the surgery with yc-1800 (b)(4) he observed focus issue. Due to focus issue he had to fire more shots which have caused the pitting lens. The pitting was not bad and pt did not have any adverse events due to this issue. Doctor could complete the treatment successfully. As per the doctor there has been no pt injury so he did not provide any pt info. The device will be evaluated at the site by the nidek field service engineer. Should new info that changes the facts and/or conclusion of this report become available, a supplemental report will be submitted. 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
[63942733]
The device has not been returned to the nidek. However field service engineer fse evaluated the device in the field. The device was tested and evaluated for proper operation. The treatment output energies were checked and were within specifications. No failure was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00026 |
| MDR Report Key | 4877814 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-06-26 |
| Date of Report | 2015-06-15 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-06-15 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2015-07-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-2/20/2015-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | ND:YAG LASER |
| Product Code | LXS |
| Date Received | 2015-06-26 |
| 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 | 2015-06-26 |