MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-11 for YC-1800 manufactured by Nidek Co., Ltd..
[19737836]
Nidek inc rec'd a complaint from a customer on (b)(6) 2015. Doctor reported that during the use of yc-1800 sn (b)(4) the explosion/burst was happening too soon. Doctor could complete the treatment by some adjustments (the details of adjustments done were not described). No pt was affected and no injury was reported at the time.
Patient Sequence No: 1, Text Type: D, B5
[20137673]
The affected device was not returned to nidek. However the device was evaluated on site by nidek field svc engineer (fse). Customer complained about bursting too soon. Customer did not know how to describe what was going on properly, but fse verified again and confirmed that the energy was unstable and doctor could not get the effect what he was trying to achieve. Fse tested the device. The actual energy output and the display energy output were tested. Fse found the actual energy was lower than the display energy. The device was out of calibration. Fse found that the optics were dirty. Dirty optics could be the reason for the low energy transfer. Fse cleaned the optics and the device was calibrated as per the specifications. The energies were tested again after the svc and the confirmed that it was within specifications. At this time no pt has been affected and hence no pt info is available. 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
| Report Number | 3002807715-2015-00024 |
| MDR Report Key | 4844620 |
| Report Source | 05,06 |
| Date Received | 2015-06-11 |
| Date of Report | 2015-05-19 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-05-19 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2015-07-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 2015-06-11 |
| 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 | 2015-06-11 |