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 2015-05-28 for YC-1800 YV-1800 manufactured by Nidek Co., Ltd..
[5833908]
Nidek inc received a complaint from a customer on (b)(6) 2015. Customer reported that doctor has been experiencing pitting lenses during the surgery with yc-1800 sn (b)(4). Doctor mentioned that they had been following all of nidek's instructions that still experiencing pitting lenses. Doctor also confirmed that there were no patient injuries sustained and no follow up appointments or surgical procedures were required at that time.
Patient Sequence No: 1, Text Type: D, B5
[13418526]
The affected device was returned to nidek on 05/18/2015. The device has been evaluated by the nidek service engineer (se). Se checked the laser aiming beam focus and alignment were verified and were within specifications. Focus shift and focus points were checked and were within the specifications. System has been tested and inspected for proper operation. Nidek clinical specialist contacted doctor to gather additional information regarding complaint and confirmed that doctor mentioned that the pitting was not bad. Patient was fine. No follow up or medical or surgical intervention was required. However doctor mentioned that there was a focus issue, focus was off and she had difficulty focusing during the surgery. Based on the evaluation nidek would like to confirm that the offset focus shift was proper and the customer complaint related to the focus issue could not be verified. However the possibility of poor focusing could be from the ocular contact lens being used such as if the contact lens is damaged or not cleaned properly can cause focus issues. As a corrective action for this nidek will be sending the sales representative/field service engineer to the field to check if the contact lens they have been using is clean; not damaged and/or if it needs to be replaced. Nidek sales representative/field service engineer will also go over with the settings with the doctor to check if the doctor has been using the correct settings as a preventive measure. Additionally she also observed laser power was low. However low power itself is not a contributing factor to the pitting. (reference: operators manual: 2. Safety and precautions; 2. 3 use; caution) power has been adjusted. The system has been calibrated. Should new information that changes the facts and/or conclusion of this report become 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
[56211025]
The device has not been returned to the nidek. However, field service engineer fse evaluated the device in the field. As per doctor focus was off and she had difficulty focusing during the surgery. Fse verified the complaint regarding focus issue and found that doctor was unaware of how to use the focus shift. Fse instructed doctor how to use the focus shift. The problem has been resolved. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00021 |
| MDR Report Key | 4808491 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-05-28 |
| Date of Report | 2015-06-11 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-06-11 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2015-06-24 |
| 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 DR. |
| 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 | 2015-05-28 |
| Returned To Mfg | 2015-05-18 |
| Model Number | YV-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 | 2015-05-28 |