MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-12 for RT-5100 manufactured by Nidek Co., Ltd.
[5767796]
Nidek inc. Received a complaint from a customer on (b)(6). Customer sent an email during a follow for the rt-5100 recall. Customer reproduced that the wear point chart arm for rt-5100 sn #(b)(4) fell down and hit the doctor on the head causing bruise.
Patient Sequence No: 1, Text Type: D, B5
[13083560]
The affected device was not returned to nidek for eval. However, the parts were returned back for the eval. This incident was confirmed to have occurred before the preventive maintenance was performed. The customer had not done the preventive maintenance; however, nidek hired third party (b)(4), technical service support to perform service for the rt-5100 recall. The service engineer performed the tilt test per recall criteria and the parts were replaced as per recall guidelines. The returned parts hinge and holder assembly were tested by in-house service engineer. On eval service engineer found hinge was loose enough for free fall of near point rod was one of the ln-screw was missing to holder assembly. Based on eval service engineer 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 contacted the customer and confirmed that the injury was minor (a small bruise) and did not seek any surgical or medical intervention. 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 | 3002807715-2015-00014 |
| MDR Report Key | 4613109 |
| Report Source | 05,06 |
| Date Received | 2015-03-12 |
| Date of Report | 2015-02-19 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2015-05-08 |
| 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 | 2015-03-12 |
| 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, HIROSHI GAMAGORI AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-12 |