MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-23 for RT-5100 manufactured by Nidek Co., Ltd.
[75929143]
No serious injury occurred, the doctor involved complaint of just being aggravated. However, nidek considers it a reportable event as the device had malfunctioned and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Nidek hired third party (b)(4) to perform the correction as per recall (z-1245-2016). At this time, device evaluation anticipated but has not begun. Therefore, a follow-up will be submitted once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[75929184]
On april 25, 2017, during a recall process, nidek inc. Recall coordinator received information from a doctor that the near point rod of rt-5100 serial #(b)(4) had hit him in the face and head on multiple occasions. On april 26, 2017, nidek inc. Mdr specialist spoke on the phone with the doctor involved. The doctor stated that the near point rod had hit him in the head hundred times over the span of 10 years. Although no bruising, no open wounds or no bumps but he felt aggravated (annoyed) but felt any medical treatment was unnecessary. He also added that there was no other patient involved.
Patient Sequence No: 1, Text Type: D, B5
[77948001]
The serial number of the device in question is entered incorrectly on initial mdr 0002936921-2017-00004 submitted on 5/23/2017. This follow-up is to provide the correct serial number.
Patient Sequence No: 1, Text Type: N, H10
[86852840]
Nidek incorporated already reported of similar adverse event to the fda and taken remedial action in 2014 (z-1853-2014). Since nidek have received similar customer complaints, additional field correction (z-1245-2016) has begun on 3/24/2016. Noritsu performed the correction as per z-1245-2016. ? On may 13, 2017, a noritsu technical service rep (tsr) conducted an onsite service repair. ? Tsr replaced the defective part with known good near point chart rod modified kit. ? Tsr verified the new part operation and observed no falls. Issue resolved and customer very satisfied. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86852841]
See initial mdr 0002936921-2017-00004 submitted on 5/23/2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00004 |
| MDR Report Key | 6586239 |
| Date Received | 2017-05-23 |
| Date of Report | 2017-06-08 |
| Date of Event | 2017-04-25 |
| Date Mfgr Received | 2017-04-25 |
| Device Manufacturer Date | 2006-11-15 |
| Date Added to Maude | 2017-05-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. PREETI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 5103537718 |
| 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 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1245-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RT-5100 |
| Generic Name | REFRACTOR |
| Product Code | HKN |
| Date Received | 2017-05-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-23 |