MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-10 for YC-1800 manufactured by Nidek Co., Ltd.
[105441474]
The doctor claimed that to successfully complete the surgery, the doctor would decrease the energy and increase the offset of the device. Nidek inc. Has learned that the doctor has doubts the effectiveness/reliability of the device in question and therefore, nidek has decided to replace it with a new yc-1800. At this time, evaluation on the yag laser has not begun, a supplemental follow-up report will be submitted once the device evaluation and repair are completed.
Patient Sequence No: 1, Text Type: N, H10
[105441475]
On (b)(6) 2018, nidek inc. Customer service manager received a phone call from a nidek inc. Field service manager to report that a customer (doctor) was complaining that the yag laser yc-1800 serial (b)(4) experiencing pitting lenses during surgery. There were three patients involved during the procedures, thereby, three individual reports will be submitted. Two patients surgeries were completed in the office without any complications and one patient had to be rescheduled for laser capsulotomy at the hospital and the surgery also was completed without any complications. There was no serious adverse events reported, patients involved did not complain of any eye complications after the surgeries but nidek inc. Considers pitting lens issue a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issue to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00002 |
| MDR Report Key | 7419964 |
| Date Received | 2018-04-10 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-08-02 |
| Date Added to Maude | 2018-04-10 |
| 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 | MR. TOSHIO MURATA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537718 |
| 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 | 0 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2018-04-10 |
| 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 | 2018-04-10 |