MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-03-22 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..
[103232516]
(b)(4). Nakanishi is now trying to obtain further information about the event including the patient.
Patient Sequence No: 1, Text Type: N, H10
[103232517]
On march 2, 2018, nakanishi received documents from an attorney by post stating that an nsk handpiece had burned a patient. Details are as follows. The event occurred on (b)(6) 2017. A dentist was extracting the patient's wisdom teeth (teeth #1, 16 and 17) using the handpiece, sga-e2s (serial no. : (b)(4)). During the surgery, an iv sedation was administered to the patient. During the surgical procedure, the dentist rested the device on the left side of the patient's lower lip. The handpiece overheated, causing serious and permanent burn injury and scarring to the patient's lower lip and chin.
Patient Sequence No: 1, Text Type: D, B5
[111460034]
On march 9, 2018, nakanishi received an e-mail from the distributor (b)(4) stating that there was neither information available about the patient nor the device returned from the customer for investigation. Due to the device not being returned from the distributor, (b)(4) (manufacturer) made the dhr examination as the investigation approach. As a result of the examination, the dhr indicated that no problems occurred during manufacturing and testing of the subject device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611253-2018-00010 |
| MDR Report Key | 7363138 |
| Report Source | OTHER |
| Date Received | 2018-03-22 |
| Date of Report | 2018-07-10 |
| Date of Event | 2017-01-03 |
| Date Facility Aware | 2018-02-20 |
| Report Date | 2018-03-19 |
| Date Reported to Mfgr | 2018-03-19 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2016-01-07 |
| Date Added to Maude | 2018-03-22 |
| 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 | ATTORNEY |
| 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# : 9611253-2018-00010 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 | 2018-03-22 |
| Model Number | SGA-E2S |
| Catalog Number | H265 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | 3 YR |
| 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 | 2018-03-22 |