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-5100 manufactured by Nidek Co., Ltd..
[5055881]
Nidek received a complaint from the customer on (b)(6) 2014. Customer reported that during the use of rt-5100 sn (b)(4), the near point chart arm fell down. The near point chart arm hit the doctor on the head. Doctor complained of bloody head due to the arm.
Patient Sequence No: 1, Text Type: D, B5
[12711236]
The affected device was not returned to nidek for evaluation. The device has not been evaluated yet. Service engineer could conduct an on-site evaluation. Customer reported that the event occurred long time back (date not specified by customer) before the pm was done. Customer then performed the preventative maintenance (pm) according to the recall procedure. The problem has been resolved after the pm. Nidek contacted the customer to verify the complaint about the injury and confirmed that the injury was minor, it was a small dent/laceration. No medical or surgical intervention was required for the injury. Nidek also confirmed that the event had occurred before the pm and the issue has been resolved after the pm. If additional significant information is received at a later date after the evaluation, a follow-up report will be submitted. Nidek inc. Considers it a reportable event as the device has malfunctioned and has a potential cause or contributed to a serious injury if the malfunction were to recur. The facility has two units sn (b)(4) and sn (b)(4) and the complaint could not be confirmed with which device the event happened. So nidek will submit two separate mdr for both the sn. Please refer to mdr 3002807715-2014-00041.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807715-2014-00040 |
| MDR Report Key | 4304379 |
| Report Source | 05,06 |
| Date Received | 2014-12-01 |
| Date of Report | 2014-11-11 |
| Date Mfgr Received | 2014-11-11 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2014-12-09 |
| 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 | FREEMONT CA 94539 |
| Manufacturer Country | US |
| Manufacturer Postal | 94539 |
| Manufacturer Phone | 5103537785 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROSHI |
| Manufacturer City | GAMAGORI, 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 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2014-12-01 |
| Model Number | RT-5100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIDEK CO., LTD. |
| Manufacturer Address | 34-14, HIROSHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-01 |