MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,oth report with the FDA on 2015-06-29 for YC-1800 manufactured by Nidek Co., Ltd. Hamacho Plant.
[6059892]
Nidek inc. Received a complaint from a customer on (b)(6) 2015. Customer reported that during the use of yc-1800 sn (b)(4). Doctor noticed pitting lens. No injury was reported and no additional information was provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[13520479]
The affected device has not been returned to nidek. The inspection has not been done yet so the results of evaluation are not available. Nidek clinical specialist contacted customer to gather additional information regarding complaint. Doctor reported that many patients were affected due to pitting. Number of patients has not been confirmed. However doctor confirmed that none of the patients had any serious adverse effect and no medical or surgical intervention was required to treat the patients. Doctor did not agree to provide additional patient information. The device will be returned to nidek and will be evaluated by the nidek service engineer at later date. 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 reoccur.
Patient Sequence No: 1, Text Type: N, H10
[34482050]
The affected device yc-1800; sn (b)(4) was returned to the nidek. The device was tested and evaluated by the nidek service engineer (se). The treatment output energies were tested and verified and were within the specifications. Focus and alignment of the yag and aiming beam were checked and were within specifications. Focus shift was checked and was okay. The device was within specifications and no failure was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00028 |
| MDR Report Key | 4886691 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-06-29 |
| Date of Report | 2015-08-25 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-08-25 |
| Device Manufacturer Date | 2010-10-01 |
| Date Added to Maude | 2015-07-23 |
| 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 | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| 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 |
| 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 | 2015-06-29 |
| Returned To Mfg | 2015-06-29 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD. HAMACHO PLANT |
| Manufacturer Address | 34-14, HIROISHI, GAMAGORI AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-29 |