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 2018-05-02 for YC-1800 manufactured by Nidek Co., Ltd.
[107855370]
On april 5, 2018, the device in question was evaluated at the user's facility by a nidek inc. Field service engineer (fse). Fse measured 56v ac from ground to headrest and body of laser. The ac power cord appears to have been stepped on the base of the alcon table. Fse removed the power cord and found damage to the end. Bad electrical grounding on ac power cord and frame of table floating at 56v ac. Fse replaced ac power cord with facility's spare power cord, and tested voltage from electrical ground to laser body to chinrest and found voltage measured at below 50mvac. Leakage voltage was now within spec. Nidek inc. Determined that root cause of the customer reported issue was due to damaged ac power cord of the alcon table. The laser was placed on ungrounded non-nidek product (alcon table) which caused high electrical leakage voltage. Thus, the issue was not caused by a nidek inc product. After the device evaluation, the laser is now operational.
Patient Sequence No: 1, Text Type: N, H10
[107855391]
On (b)(6) 2018, nidek inc. Received a phone call from a customer stating that while the user's facility doctor was performing a procedure on a patient, an electrostatic shock felt to the right hand of the doctor and at the same time, the patient also felt the electrostatic to the left eye. The procedure was paused and will resume after the laser evaluation. At this time, nidek has no additional information of doctor and patient condition but a supplemental follow-up will be submitted once become available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2018-00006 |
| MDR Report Key | 7481640 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-02 |
| Date of Report | 2018-05-25 |
| Date of Event | 2018-04-03 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2009-10-09 |
| Date Added to Maude | 2018-05-02 |
| 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 | MR TOSHIO MURATA |
| 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 | 2018-05-02 |
| 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 AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |