MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2015-02-25 for RT-5100 manufactured by Nidek Co., Ltd..
[16541541]
Nidek inc. Received a complaint from a customer on (b)(6) 2015. Customer sent an email during a follow for the rt-5100 recall. Customer reported that the near point chart arm for rt-5100 sn. (b)(4) kept falling down and once hit the doctor on the nose causing bloody nose.
Patient Sequence No: 1, Text Type: D, B5
[16694320]
The affected device was not returned to nidek for evaluation. However, a nidek service engineer (se) had conducted an on-site evaluation. The evaluation was conducted as per recall procedure. Based on evaluation nidek se found the near point chart arm hinge was not properly bolt to the holder assembly, which caused the free fall of near point chart arm. This incident was confirmed to have occurred after the preventive maintenance was performed. The near point chart rod could not pass the tilt test per recall criteria and replacing parts were required as per recall guidelines. Se replaced the complete set of holder assembly and the system was tested for proper operation and has been functional. Based on evaluation se confirmed that the cause was related to the prolonged use of the device causing wear and tear which was observed on the parts and is related to the recall. Nidek also confirmed that it caused the doctor's nose to bleed once the rod falling on her. But it was not serious and did not require any additional attention. Nidek inc. 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
| Report Number | 3002807715-2015-00013 |
| MDR Report Key | 4576434 |
| Report Source | 04,05 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-02 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2015-02-02 |
| Date Added to Maude | 2015-04-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | NEO YAMAGUCHI |
| Manufacturer Street | 47651 WESTINGHOUSE DR. |
| Manufacturer City | FREMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| 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 | Z-1853-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2015-02-25 |
| Model Number | RT-5100 |
| 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, HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-25 |