MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-07-15 for YC-1800 manufactured by Nidek Co., Ltd..
[16493345]
Nidek inc. Received a complaint from a customer on 06/16/2015. Nidek recall team contacted the customer regarding yc-1800 recall team contacted the customer regarding yc-1800 recall that time technician reported that doctor does have pitting lens occasionally during the use of laser yc-1800 sn:(b)(4). No other information was provided at that time.
Patient Sequence No: 1, Text Type: D, B5
[16695274]
The affected device has not been returned to nidek and has not evaluated so the results of evaluation are not available at this time. Nidek customer service manager contacted customer to gather additional information regarding the complaint. Customer did not provide any additional details regarding the date of occurrence, number of patients and age/gender of patients. Nidek requested customer to do service and evaluation of the device. Doctor refused to perform service at this time. However nidek will do the field service for this device at later date. If additional significant information is received at a later date, a follow-up report will be submitted. Nidek will be submitting one mdr for this complaint as number of the events occurred could not be confirmed. 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 | 3002807715-2015-00034 |
| MDR Report Key | 4921046 |
| Report Source | 05,06 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-06-16 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-06-16 |
| Device Manufacturer Date | 2006-08-01 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5103537785 |
| 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 | 2015-07-15 |
| 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 | 2015-07-15 |