MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for YC-1800 manufactured by Nidek Co., Ltd..
[26052090]
The device was not returned back to nidek. However the device was evaluated by the nidek field service engineer (fse) at the site. The device was tested and evaluated for proper operation. The treatment output energies were checked and were within specifications. Focus shift and focus points were checked and were within the specifications. The focus issue could not be duplicated by fse. On visual inspection fse observed dust on the oculars. The objective lens and oculars were cleaned. However the possibility of dirty oculars resulting in the focus issue could not be rejected. On further investigation it was confirmed that the device had been serviced after four years. Lack of service could be the cause for accumulation of dust on the oculars. Nidek clinical specialist contacted customer to gather additional information regarding the reported event and confirmed that the many patients were affected however doctor could complete the surgery in all cases and there was no adverse event to the patient. The number of patients affected could not be confirmed as the technician said that doctor did not keep the record of number of patients as no injury/adverse event occurred, so no additional patient information is available. Nidek clinical specialist also confirmed that the facility received the recall notification letter and reassured that doctor needs to follow the operators manual to prevent the occurrence of pitting lens in future. 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
[26052091]
Nidek inc received a complaint on (b)(6) 2015. Doctor reported that he had seen pitting in many patients. However he could complete the surgery in all of them without any adverse events. Doctor also complained about focus issues with the device. No additional information was provided at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2015-00048 |
| MDR Report Key | 5073850 |
| Date Received | 2015-09-10 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-08-11 |
| Device Manufacturer Date | 2011-03-24 |
| Date Added to Maude | 2015-09-14 |
| 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 NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| 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 | 0 |
| Brand Name | YC-1800 |
| Generic Name | ND: YAG LASER |
| Product Code | LXS |
| Date Received | 2015-09-10 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-09-10 |