MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for RT-5100 manufactured by Nidek Co., Ltd..
[44754865]
Nidek had already reported to fda similar adverse event and taken remedial action in 2014 (z-1853-2014). Nidek also has begun additional field correction (z-1245-2016) on 3/24/2016 since nidek received similar customer complaints. Based on our database, nidek was able to confirm this rt-5100(serial number (b)(4)) is within the scope of the ongoing recall (z-1245-2016). The affected device was not returned to nidek for evaluation. However, nidek hired third party (b)(4) visited the customer site for on-site evaluation and performed the correction as per the recall. Nidek confirmed that the injury was minor and did not need any surgical or medical intervention. Nidek considers it 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
[44754866]
Nidek inc. Received a complaint from a distributor on (b)(6) 2016. Customer called our us distributor and reported that the near point chart arm for rt-5100 sn. (b)(4) kept falling down and have hit the technicians once and the doctor twice in the head. Customer reported about the small bruise that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2016-00017 |
| MDR Report Key | 5626380 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-04 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2016-04-04 |
| Device Manufacturer Date | 2008-01-24 |
| Date Added to Maude | 2016-05-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PREETI GANDHI |
| 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 |
| Removal Correction Number | 2936921-02/12/2016-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2016-05-03 |
| Model Number | RT-5100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| 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 | 2016-05-03 |