MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-16 for YC-1800 manufactured by Nidek Co. Ltd..
[19087540]
Nidek received a complaint from customer on (b)(6) 2014. Doctor reported that the yc-1800 sn (b)(4) has not been functioning correct for a while. Doctor mentioned that he had noticed pitting lens during the laser surgery with this unit.
Patient Sequence No: 1, Text Type: D, B5
[19124906]
The device has not been returned to nidek. However the field service engineer will do the inspection at the customer site. The inspection is not done yet so the results of evaluation are not available. Nidek contacted the customer to verify the complaint. Doctor mentioned that though he had seen pitting lens cases so far there is no injury or any adverse event to the patient. The patient have been doing fine. Doctor also reported that the problem has been there for past two years however it is difficult to estimate the total number of patients. Nidek could not confirmed the number of patients affected. Nidek will submit one single mdr for this event at this time. If additional significant information is received at a later date, a follow-up report and additional mdr will be submitted for additional confirmed event. 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 | 3002807715-2014-00043 |
| MDR Report Key | 4357960 |
| Report Source | 05,06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-11-20 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2015-01-02 |
| 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 | 2014-12-16 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-12-16 |