MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-16 for RT-5100 manufactured by Nidek Co., Ltd..
[21565738]
Nidek received a complaint from the customer on (b)(6) 2014. Customer reported about an injury to the technician while using rt-5100, sn: (b)(4). Customer reported that the near point chart arm fell down and scratched the cornea of one of the technicians.
Patient Sequence No: 1, Text Type: D, B5
[21689614]
The affected device was not returned to nidek for evaluation. However, a nidek service engineer (se) had conducted an on-site evaluation. 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. Se replaced the complete set of holder assembly. The system was tested for proper operation and has been functional. Nidek clinical specialist contacted the technician and verified about the complaint. Technician reported that on (b)(6) 2014 she got corneal injury due to the near point chart arm of rt-5100 which fell down and hit her cornea. On examination by slit lamp and fluorescein staining doctor noticed a corneal abrasion. The abrasion was treated by bandage contact lens for overnight followed by tear drops (as needed) for the next day. The technician felt better after two days. Nidek inc considers it a reportable event as the device has malfunctioned and had resulted an injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2014-00044 |
| MDR Report Key | 4357961 |
| Report Source | 05,06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-11-26 |
| Date of Event | 2014-11-25 |
| Date Mfgr Received | 2014-11-26 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2015-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2014-12-16 |
| 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 | 2014-12-16 |