MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-12-01 for RT-1500 RT-5100 manufactured by Nidek Co., Ltd..
[5055882]
Nidek received a complaint from the customer on (b)(6) 2014. During the use of rt-5100; sn (b)(4), the near point chart arm fell down and hit the doctor on his nose. Doctor got cut on his nose. Doctor also reported that this incident happened after the preventive maintenance was done for the recall.
Patient Sequence No: 1, Text Type: D, B5
[12711238]
The affected device was not returned to nidek for evaluation. However, a nidek service engineer (se) had conducted an on-site evaluation. The device was evaluated. Se found the hinge (p/no. 82001cb033) had degraded failure. The part was replaced and the preventive maintenance was done according to the recall procedure. The near point chart arm has been fixed. Nidek contacted the customer to verify the complaint about the cut on the nose and confirmed that the injury was minor. No medical or surgical intervention was required for the injury. 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 | 3002807715-2014-00037 |
| MDR Report Key | 4304381 |
| Report Source | 05,06 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-05 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2014-11-05 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2014-12-12 |
| 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 DRIVE |
| 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-1500 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2014-12-01 |
| 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 | 2014-12-01 |