MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-05 for YC-1800 manufactured by Nidek Co.,ltd.
[88230552]
Nidek inc. Considers pitting lens issue on yag laser a reportable event as the yc-1800 had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Device evaluation is in work process. A follow-up report will be submitted once the device evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[88230553]
On (b)(4) 2017, nidek inc. Customer service received a telephone call from a customer to report that the doctor observed pitting lens during surgical procedure. However, the user's facility claimed that there was no serious adverse event in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00023 |
| MDR Report Key | 6915805 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-05 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-09-08 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2014-10-01 |
| Date Added to Maude | 2017-10-05 |
| 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 | MRS. PREETI GANDHI BHATIA |
| 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 | 3 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2017-10-05 |
| 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 | 2017-10-05 |