MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-23 for YC-1800 manufactured by Nidek Co., Ltd. Hamacho Plant.
[5240457]
Nidek received a complaint from the customer on (b)(4) 2014. Customer reported that the laser yc-1800; sn (b)(4) has not been working properly. The laser energy is being delivered too diffusely. Customer mentioned that there is too much energy anterior and posterior to the center of focus.
Patient Sequence No: 1, Text Type: D, B5
[12633735]
The device has not been returned to nidek. The inspection has not been done yet, so the results of evaluation are not available. Nidek contacted the customer to verify the complaint and also confirmed that at this point, none of the surgeons have reported a patient injury due to the laser. If additional significant information is received at a later date, a follow-up 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
| Report Number | 3002807715-2014-00045 |
| MDR Report Key | 4379445 |
| Report Source | 05,06 |
| Date Received | 2014-12-23 |
| Date of Report | 2014-12-03 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-12-03 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2015-01-14 |
| 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 DRIVE |
| Manufacturer City | FREEMONT CA |
| Manufacturer Country | US |
| Manufacturer Phone | 5103537785 |
| Manufacturer G1 | NIDEK CO., LTD. HAMACHO PLANT |
| 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 | 2014-12-23 |
| 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. HAMACHO PLANT |
| Manufacturer Address | 34-14M HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-23 |