MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-15 for YC-1800 manufactured by Nidek Co. Ltd..
[111490303]
The device was evaluated by nidek field service engineer (fse) on 06/12/2018 at the user facility. The customer reported issue "display energy jump up/down during the procedure" could not be verified or duplicated. Powered on the system and found in working order. The following are the service activities performed:? Performed pfn (pulse forming network) voltage calibration. ? Performed energy monitor calibration. ? Checked and verified the displayed energy and actual energy for 0. 3/1. 0/3. 0/5. 0/7. 5/10. 0mj. ? Checked and verified the display energy is not jumping up/down during procedure. ? Checked and verified yag focus shift. ? Checked and verified aiming beam alignment. ? Checked and verified mechanical and operational function of the unit. System is operational. Fse revisited the user facility the following day, on (b)(6) 2018 upon the customer's request for observing the procedure with doctor and found satisfactory. Customer reported issue "display energy up/down during the procedure" is inconclusive. No injuries reported, however, nidek inc. 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
[111490304]
Nidek inc. Received a complaint from the customer on (b)(6) 2018. Customer reported that while performing procedures with the yc-1800 sn: (b)(4), doctor noticed that the power on laser was increasing. Doctor had to manually lower the energy on the unit. No injury was reported at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00008 |
| MDR Report Key | 7607909 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-15 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-05-23 |
| Date Mfgr Received | 2018-05-23 |
| Device Manufacturer Date | 2007-02-08 |
| Date Added to Maude | 2018-06-15 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. TOSHIO MURATA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YC-1800 |
| Generic Name | YAG LASER |
| Product Code | LXS |
| Date Received | 2018-06-15 |
| Model Number | YC-1800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-06-15 |