MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-12-20 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..
[131140676]
(b)(4). Nakanishi is currently trying to obtain further information about the event and patient.
Patient Sequence No: 1, Text Type: N, H10
[131140677]
On (b)(6) 2018, nakanishi received an e-mail from a distributor (b)(4) about a handpiece overheating. According to (b)(4), 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 | 9611253-2018-00066 |
| MDR Report Key | 8186537 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2015-07-01 |
| Date Facility Aware | 2018-12-04 |
| Report Date | 2018-12-05 |
| Date Reported to Mfgr | 2018-12-05 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-12-20 |
| 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# : 9611253-2018-00066 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 | 2018-12-20 |
| 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 | 2018-12-20 |