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 2016-05-31 for RT-5100 manufactured by Nidek Co., Ltd..
[46254188]
Nidek had already reported to fda similar adverse event and remedial action had taken 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
[46254189]
Nidek received a complaint from a distributor on 04/27/2016. Nidek hired third party, (b)(4) called this customer on 04/26/2016 to schedule installation of the nidek near point arm upgrade to perform field correction (z-1245-2016). During the conversation, the office manager immediately reported that there was an incident earlier today where the near point rod actually fell on the doctor striking him first in the forehead, and then on the bridge of his nose causing some noticeable marks where it struck him. The force caused a small cut on his forehead and bridge of the nose. He did not require medical attention, but the site is tender to the touch.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807715-2016-00018 |
| MDR Report Key | 5690287 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-31 |
| Date of Report | 2016-04-27 |
| Date of Event | 2016-04-26 |
| Date Mfgr Received | 2016-04-27 |
| Device Manufacturer Date | 2012-04-09 |
| Date Added to Maude | 2016-05-31 |
| 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 | 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2936921-02/12/2016-001-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2016-05-31 |
| Model Number | RT-5100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-31 |