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 2015-05-05 for YC-1800 manufactured by Nidek Co., Ltd..
[18262620]
Nidek inc received a complaint from a customer on (b)(6) 2015 regarding yc-1800 sn (b)(4). Customer sent in a letter with yc-1800 recall notification. Customer complaint about two recurring problems associated with the yc-1800. The first is that the laser fires blanks and the second is lens pitting. Doctor explained about the firing blanks as when he pressed the trigger to fire the laser he heard a typical clicking sound but did not see any energy delivered and no change to the capsule, lens or no gas bubble formation. According to the customer he informed this issue to one of the nidek representatives at one of the (b)(6) meetings. The laser was exchanged soon after that. The problem was better for a while, but they had the same problem with the second laser. Nidek representative suggested the doctor to increase the energy of the laser to avoid the problem of firing blanks. This seemed to help that problem, but increased the risk of lens pitting. Doctor also informed that he has received a notification letter regarding the yc-1800 recall and has reread the operator's manual and followed the procedures. This did seem to help slightly with the problem of lens pitting, but has not resolved it and the problem of firing blanks is still there. No injury was reported at this time.
Patient Sequence No: 1, Text Type: D, B5
[18551483]
The affected device has not been returned to nidek. The evaluation has not done yet so the results of evaluation are not available. Nidek contacted the facility and talked to the doctor regarding the letter he sent in with the recall notice. Doctor reported that there is no patient injury and no surgical treatments needed to repair any injury. Nidek confirmed that there is no confirmed incidence of pitting lens at this time. Doctor mentioned that the reason to report a complaint was that he was dissatisfied as a physician as his laser was not treating as it should. Nidek will submit the follow up report if additional significant information is received at a later date after the evaluation. 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
[63941216]
The affected device yc-1800; sn (b)(4) was returned to the nidek on (b)(6) 2015. The device was tested and evaluated by the nidek service engineer (se). The treatment output 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. Focus shift was checked and was okay. Optical breakdown was within specifications. The device was within specifications and no failure was found. The device was calibrated and tested for proper operation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2015-00019 |
| MDR Report Key | 4759873 |
| Report Source | 05,06,HEALTH PROFESSIONAL,OTH |
| Date Received | 2015-05-05 |
| Date of Report | 2015-06-29 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-06-29 |
| Device Manufacturer Date | 2012-09-01 |
| Date Added to Maude | 2015-06-25 |
| 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 | 2015-05-05 |
| Returned To Mfg | 2015-06-11 |
| 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. |
| Manufacturer Address | 34-14, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |