MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-30 for YC-1800 manufactured by Nidek Co., Ltd..
[27213134]
The device has not been returned to the nidek however the device was evaluated at the filed by the field service engineer (fse). The device was tested and inspected for proper operation. Aiming beam out of focus issue could not be duplicated. The aiming beam focus was tested for proper functioning and no problem was found. Fse also discussed the focus issue with the doctor and suggested to use new abraham lens with the focus shift setting of 250 instead of 450 focus shift. As per operators manual it is recommended that doctor should use abraham lens during surgery. (reference: ophthalmic yag laser system yc-1800 operator's manual; 4. 4 preparing for treatment; 12. Caution). Failure to use contact lens could cause focus issue as the use of contact lens facilitates accurate focusing. (reference: http://www. Aao. Org/munnerlyn-laser-surgery-center/ndyaglaser-posterior-capsulotomy-3). Additionally fse also tested the device for low power issue. The low power issue was duplicated and verified by the fse. Service was performed and power has been adjusted according to specifications. The system was calibrated. However low power issue does not has a potential to cause an adverse event even if the issue reoccurs. (reference: operators manual: 2. Safety and precautions; 2. 3 use; caution) nidek considers this failure mode as a reportable event as the device has malfunctioned and the recurrence of the focus issue has potential to cause or contribute to an adverse event.
Patient Sequence No: 1, Text Type: N, H10
[27213135]
Nidek inc. Received a complaint from a customer on (b)(6) 2015. Customer reported that during the use of yc-1800 sn: (b)(4) doctor noticed that the aiming beam was out of focus. Doctor also observed low power in the laser. The issue was observed during the testing of the device and no patient was affected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2015-00047 |
| MDR Report Key | 5115050 |
| Date Received | 2015-09-30 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-21 |
| Device Manufacturer Date | 2010-11-02 |
| Date Added to Maude | 2015-09-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEO YAMAGUCHI |
| 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 | 0 |
| Brand Name | YC-1800 |
| Generic Name | ND : YAG LASER |
| Product Code | LXS |
| Date Received | 2015-09-30 |
| Model Number | YC-1800 |
| Operator | PHYSICIAN |
| 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 | 2015-09-30 |