MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-31 for NSK SGS-E2S H266 manufactured by Nakanishi Inc..
[118933912]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[118933913]
On (b)(6) 2018, nakanishi received an e-mail from a distributor (nsk america) about a handpiece overheating. Details are as follows. The event occurred on (b)(6) 2018. A dentist was performing a wisdom tooth extraction on the lower right quadrant using the sgs-e2s handpiece (serial no. : (b)(4)). When splitting the tooth in half, the dentist noticed a white mark inside of the patient's lower right lip, which was a first degree burn. According to the dentist, there were no abnormalities of the handpiece observed prior to use. The dentist immediately applied ice to the burn and continued the dental procedure. After the procedure was completed, the dentist applied ice again and administered hydrocortisone cream to the injury. The patient had a follow up visit on july 18, 2018 and was healing normally. No further medical intervention is required to treat the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2018-00038 |
| MDR Report Key | 7837011 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-31 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-07-16 |
| Date Facility Aware | 2018-07-27 |
| Report Date | 2018-08-09 |
| Date Reported to Mfgr | 2018-08-09 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2015-06-30 |
| Date Added to Maude | 2018-08-31 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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# : 9611253-2018-00038 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 | 3 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2018-08-31 |
| Returned To Mfg | 2018-08-21 |
| Model Number | SGS-E2S |
| Catalog Number | H266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 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 | 2018-08-31 |