MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-11-16 for NSK SGS-E2G H185 manufactured by Nakanishi Inc..
[127541171]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[127541172]
On october 25, 2018, nakanishi received an e-mail from a distributor ((b)(4)) about a handpiece overheating. Details are as follows. The event occurred around (b)(6) 2018 (exact date is unknown). The dentist was performing an extraction of impacted 3rd molars on patient using the sgs-e2g handpiece (serial no. (b)(4)). The patient was under local anesthesia (iv sedation). During the procedure, the dentist noticed sloughing and a burn in the extra intraoral labial mucosa skin of the left lip. The dentist observed that the patient suffered a second degree burn approximately 2cm in size on the lower left lip extra intraoral labial mucosa and inferior skin. The dentist prescribed daily vaseline and vitamin e coverage with a change to silicone gel thereafter, and recommended daily coverage to prevent sun exposure as well. The dentist has conducted follow up visits since the injury and the patient has healed normally with small scarring of the skin directly under lower left lip. The dentist has stated that no further medical attention is required for treatment of this injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2018-00052 |
| MDR Report Key | 8081158 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-11-16 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-09-17 |
| Date Facility Aware | 2018-09-17 |
| Report Date | 2018-10-25 |
| Date Reported to Mfgr | 2018-10-25 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2010-02-26 |
| Date Added to Maude | 2018-11-16 |
| 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 | 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# : 9611253-2018-00052 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 | 2018-11-16 |
| Returned To Mfg | 2018-11-07 |
| Model Number | SGS-E2G |
| Catalog Number | H185 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 8 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 | 2018-11-16 |