MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-14 for RT-5100 manufactured by Nidek Co., Ltd..
[80281664]
No serious injury occurred and no known impact or consequence to the doctor involved. However, nidek incorporated considers this issue 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 inc. Is aware of this issue and corrective action has been implemented under recall z-1245-2016. Nidek hired a third party (b)(4) to performed the correction as per z-1245-2016.
Patient Sequence No: 1, Text Type: N, H10
[80281665]
On (b)(6) 2017, during recall process, a nidek incorporated recall coordinator received information from a customer that the near point chart rod on their rt-5100 serial #(b)(4) fell several times and had hit her and another employee on the head on multiple occasions. The complainant claimed that no bruise or no serious injury occurred, and thereby, medical treatment/intervention was unnecessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00016 |
| MDR Report Key | 6716033 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-14 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-06-30 |
| Date Mfgr Received | 2017-06-30 |
| Device Manufacturer Date | 2011-07-21 |
| Date Added to Maude | 2017-07-14 |
| 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 GANDHI BHATIA |
| Manufacturer Street | 47651 WESTINGHOUSE DRIVE |
| Manufacturer City | FREMONT CA 945397474 |
| Manufacturer Country | US |
| Manufacturer Postal | 945397474 |
| Manufacturer Phone | 8002239044 |
| Manufacturer G1 | NIDEK CO., LTD. |
| Manufacturer Street | 34-14 HIROISHI |
| Manufacturer City | 443-0038 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 443-0038 |
| Single Use | 3 |
| Remedial Action | RC |
| 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 | 2017-07-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-07-14 |