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 2015-07-15 for YC-1800 manufactured by Nidek Co., Ltd..
[20069755]
Nidek inc. Received a complaint from a customer on (b)(6) 2015. After nidek recall team contacted customer regarding yc-1800 recall, doctor called to report the pitting lens complaint. No other information was provided at the time.
Patient Sequence No: 1, Text Type: D, B5
[20287542]
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 doctor to gather additional information regarding the complaint. Doctor reported that she had observed pitting lens in the past but there was no patient injury and no medical or surgical intervention was required. However additional details regarding the date of occurrence, number of patients, age/gender was not provided. 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 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
[34205273]
The device has not been returned to nidek. However field service engineer (fse) evaluated the device at site on (b)(6) 2015. The device was tested and evaluated. Treatment energy and the display energy were tested and were within specifications. Yag/ aiming coincidence and offset shift was verified and no failure was found. On visual inspection fse observed dirty optics. Fse also confirmed that no preventive maintenance had been performed on the laser for past few years that could be the reason for the dirty optics and the poor performance of the laser. Fse also checked the user settings and observed that doctor was using the 0 offset. Fse explained the doctor and went over the offset function of the yc1800 and proper offset settings for capsulotomies, which is 125 - 250 microns posterior. Nidek considers that the poor functioning of the device due to lack of preventive maintenance and user not using the correct settings are the most likely causes for pitting of the lens in this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00035 |
| MDR Report Key | 4921031 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-07-15 |
| Date of Report | 2015-09-21 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-09-21 |
| Device Manufacturer Date | 2005-05-01 |
| 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 | 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 | 2015-07-15 |
| 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 |