MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-25 for NSK SGS-E2S H266 manufactured by Nakanishi Inc..
[73624633]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[73624634]
On april 6, 2017, nakanishi received an e-mail from a distributor ((b)(4)) about a handpiece overheating. Details are as follows. - on (b)(6) 2017, (b)(4) was made aware of the event by an nsk sales representative. - the event occurred on (b)(6) 2017. - a dentist was performing a surgical extraction of tooth #3 on a patient using an nsk handpiece, sgs-e2s (serial no. (b)(4)). - the patient was under local anesthesia. - during the procedure, the handpiece overheated and the patient complained about a burning sensation on the corner of the outer lip. - the dentist found a superficial epidermal burn, 6mm in diameter on the skin of the lower lip inferior lateral to commissure. - the dentist applied hawaiian moon aloe vera to the patient's skin. - no follow-up was scheduled with the patient. - the patient has recovered from the burn injury. - according to the dentist, there were no abnormalities or malfunctions observed with the handpiece prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2017-00021 |
| MDR Report Key | 6519384 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-25 |
| Date of Report | 2018-07-10 |
| Date of Event | 2017-03-21 |
| Date Facility Aware | 2017-03-27 |
| Report Date | 2017-04-06 |
| Date Reported to Mfgr | 2017-04-06 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2017-04-25 |
| 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# : 9611253-2017-00021 700 SHIMOHINATA |
| Manufacturer City | KANUMA-SHI, TOCHIGI-KEN 322-8666 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 322-8666 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | 9611253-060818-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2017-04-25 |
| Returned To Mfg | 2017-04-14 |
| Model Number | SGS-E2S |
| Catalog Number | H266 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-25 |