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 2018-04-27 for YC-1800 manufactured by Nidek Co., Ltd.
[107332500]
On 4/18/2018, the device in question was evaluated at the user's facility by a nidek inc. Field service engineer (fse). Fse turned on laser, checked the focus shift off-set with micrometer and at zero (0) off-set. Off-set was 50 microns anterior (within acceptable range of 0 to? 50 microns). Also checked actual energy, at a displayed value of 4. 4mj on laser the field max meter reads 4. 2mj (within acceptable range to preset value? 15 %). Fse adjusted the focus shift off-set to zero micron and adjusted display to match field max readings and retested the laser. As expected, the laser is operational at all settings after the service was completed. Nidek inc. Determined that most probable cause of the pitting lens reported was due to the combination of focus shift off-set being set less than indicated and user not properly aligning the x/y axis during the procedures.
Patient Sequence No: 1, Text Type: N, H10
[107332501]
On (b)(6) 2018, nidek inc. Received a phone call from a customer stating that for the past three (3) weeks, their yc-1800 has been pitting lenses while performing procedures on patients. The customer claimed by turning the laser off and on, the procedures can be executed with no issues. At this time, nidek incorporated has no information of how many patients were involved. Nidek made several emails and phone calls attempts, however no reply or response from the customer. A supplemental follow-up report will be submitted once patient(s) information are available. Thus, nidek inc. Considers pitting lens issue a reportable event as it is an undesirable condition and has a potential to cause or contribute to a serious injury if the issue to recur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00005 |
| MDR Report Key | 7470961 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-04-27 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-03-14 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2013-01-15 |
| Date Added to Maude | 2018-04-27 |
| 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 | MRS. PREETI GANDHI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537718 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 MAEHAMA, 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 | 2018-04-27 |
| 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 MAEHAMA, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-27 |