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.
[6059897]
Nidek inc. Received a complaint from a customer on (b)(6) /2015. Customer reported that during the use of yc-1800, (b)(4), it sometimes shoots at 3mj when set at 1. 3mj. Doctor also reported that laser sometimes misfires. Doctor mentioned that he observed some pitting in lens. He could complete the treatment and no injury was reported at this time.
Patient Sequence No: 1, Text Type: D, B5
[13958815]
The affected device was returned to nidek on 06/16/2015. The device evaluated by nidek service engineer (se). Focus and alignment of yag laser and aiming beam were checked and was properly aligned. The focus shift was proper. Actual energy and display energies were measured. The actual energy output was low than the display energy. Internal and external optics were checked and were found dirty. Se cleaned the optics. The device was calibrated. Energy output was checked again and was within specifications. The dirty oculars could have caused the low energy output and or misfire. However the possibility of user increasing the display energy due to misfire could not be rejected which could cause the burst of high energy output. The device was repaired and returned to the customer. On 06/25/2015 doctor contacted nidek again and reported that there has been more energy output than before and he is seeing more pitting than before. Doctor also confirmed that the pitting did not affect the patient visually. However no additional data related to the patient was provided by the doctor. Nidek qa manager, service engineer and clinical specialist visited doctors office on (b)(6) 2015. The device has been evaluated onsite by the nidek team. The energy outputs were checked and confirmed that the outputs were within specifications. Doctor's complaint regarding high energy could not be verified. However upon further discussion with doctor nidek team confirmed that the complaint is mainly related to the focus issue than the energy output. Nidek team decided to bring the unit back to nidek for further evaluation. After the evaluation once the new information that changes the facts and/or conclusion of this report becomes available, a supplemental 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 recur.
Patient Sequence No: 1, Text Type: N, H10
[35137159]
The device was returned back to nidek on 6/26/2015. The device was evaluated and tested for proper operation. The focus issue could not be duplicated. Treatment 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. Optical breakdown was within specifications. Focus off shift was proper. No failure was found. As per the initial investigation nidek service engineer found the dirty optics which could have caused the failure of the device and could be the cause of the pitting lens. However the complaint of focus issue could not been duplicated and no failure was found related to the focus issue. However, the possibilities of failure to follow the preparation and operation procedure mentioned in the operators manual by users as per recall could not be rejected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00027 |
| MDR Report Key | 4886710 |
| 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 | 2005-11-01 |
| 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. HAMACHO PLANT |
| 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 | 2015-06-26 |
| 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 |