MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..
[132497331]
(b)(4). - nsk america corp. Is listed here in and mr. (b)(6) because mr. (b)(6) is the official correspondent of both (b)(4). Nakanishi is currently trying to obtain further information about the event and patient.
Patient Sequence No: 1, Text Type: N, H10
[132497332]
On (b)(6) 2018, nakanishi received an e-mail from a distributor (nsk america) about a handpiece overheating. According to nsk america (nam), the information was provided through the adverse event questionnaire about the sgs/sga handpieces as a part of recall activities for those devices. The details are as follows. The event occurred in (b)(6) 2015. (the exact date is unknown. ) a dentist was performing a dental procedure using the sga-e2s handpiece (serial no. Unknown). During the procedure, the handpiece overheated and burned a patient's lip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2019-00001 |
| MDR Report Key | 8229060 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-07-10 |
| Date of Event | 2015-07-01 |
| Report Date | 2018-12-18 |
| Date Reported to Mfgr | 2018-12-18 |
| Date Mfgr Received | 2019-06-13 |
| Date Added to Maude | 2019-01-08 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR KENNETH BLOCK |
| Manufacturer Street | 800 E CAMPBELL RD. SUITE 202 |
| Manufacturer City | RICHARDSON TX 75081 |
| Manufacturer Country | US |
| Manufacturer Postal | 75081 |
| Manufacturer Phone | 9724809554 |
| Manufacturer G1 | NAKANISHI INC. REGISTRATION NUMBER : 9611253 |
| Manufacturer Street | MFR RPT# : 9611253-2019-00001 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 9611253-060818-001-R |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2019-01-08 |
| Model Number | SGA-E2S |
| Catalog Number | H265 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAKANISHI INC. |
| Manufacturer Address | 700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-08 |