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 2017-11-30 for RT-5100 manufactured by Nidek Co., Ltd..
[94227077]
No serious injury occurred and no known impact or consequence to the employee (user's facility technician) that was 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 (noritsu) to perform the correction as per z-1245-2016 and has completed the repair service on 11/16/2017.
Patient Sequence No: 1, Text Type: N, H10
[94227078]
On (b)(6) 2017, a nidek inc. Customer service received an e-mail information from a customer that the near point rod from rt-5100 serial #(b)(4) had hit her on the head during set-up. Customer stated she did not have any open wound, bruise, or bump and did not seek any medical treatment. She was the only technician involved in this reported issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002936921-2017-00025 |
| MDR Report Key | 7072065 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-30 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-11-07 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2010-11-05 |
| Date Added to Maude | 2017-11-30 |
| 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 | 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 | 2017-11-30 |
| 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 | 2017-11-30 |