MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-04-11 for RT-5100 REFRACTOR manufactured by Nidek Co.. Ltd.
[4431880]
Nidek inc received a complaint from a customer on (b)(6) 2013 through u. S. Distributor, (b)(4). Rt-5100 near point rod fell down and hit the doctor's nose when he used the rt-5100 (s/no. (b)(4)). The doctor obtained a laceration on his nose. We tried to contact through our distributor and meet with the doctor. However, our visit was refused by the doctor because he thought it was a non-serious injury. Nidek inc and (b)(4) confirmed that his injury was not serious; therefore, there was no need for further follow-up investigation to injury level as of (b)(6) 2013. As nidek (b)(4) investigated the device returned, they found the near point rod holder was bent. It was evaluated that too much pressure was applied to the hinge axis connected to the near point rod holder. As the result, the screw may become loosen or the hinge might be broken. During a teleconference with fda (b)(4) district office and on (b)(4) 2014, nidek inc was advised by a doctor in (b)(4) that a complaint relating laceration of the nose was a serious injury as she said "i would consider any injury to the face that can cause scarring a serious injury and it is reportable. " we determined to submit this mdr to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11847617]
Nidek inc was under fda inspection from (b)(4) 2014 and it's still ongoing. We are preparing a correction report to fda and had a opportunity to discuss on our correction strategy with (b)(4) district office and (b)(4). During a teleconference with them on (b)(4), nidek inc was advised by a doctor in (b)(4) that a complaint relating laceration of the nose was a serious injury as follows "i don't think the firms' analysis or strategy is appropriate. I would consider by injury to the face that can cause scarring a serious injury and it is reportable. " we determined we submit a mdr to fda based on the advise from (b)(4). We sincerely apologize we did not submit this mdr within 30 calender days. On the other hand, our correction strategy in the draft of customer notification latter was accepted by all fda attendees in the teleconference on (b)(4). Our strategy is to provide preventive maintenance kit including hex wrench, glue and instruction for use to all customers who purchased rt-5100 or rt-3100.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936921-2014-00001 |
| MDR Report Key | 3786848 |
| Report Source | 06 |
| Date Received | 2014-04-11 |
| Date of Report | 2013-05-14 |
| Date of Event | 2013-05-14 |
| Date Mfgr Received | 2013-05-14 |
| Device Manufacturer Date | 2011-06-14 |
| Date Added to Maude | 2014-05-05 |
| 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 | 5102265700 |
| Manufacturer G1 | NIDEK CO., LTD |
| Manufacturer Street | 34-14 MAEHAMA, HIROISHI-CHO GANMAGORI |
| Manufacturer City | AICHI 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 REFRACTOR |
| Generic Name | NONE |
| Product Code | HKN |
| Date Received | 2014-04-11 |
| Returned To Mfg | 2013-06-18 |
| 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 MAEHAMA HIROISHI-CHO, GAMAGORI AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-11 |