MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-05-12 for NSK SGS-E2S H266001 manufactured by Nakanishi Inc..
[75089018]
(b)(4). The information received from (b)(4) is as follows. - on april 17, 2017, and april 20, 2017, (b)(4) contacted the dental office by phone and email to request patient information, but the dental office did not disclose the patient information. - no service has been conducted at (b)(4) on the subject device ((b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[75089019]
On april 24, 2017, nakanishi received an email from a distributor ((b)(4)) describing a patient injury. Details are as follows. - on april 13, 2017, (b)(4) was made aware of an unconfirmed patient injury from information provided from the incoming service repair paperwork. - the event occurred on (b)(6) 2017. - (b)(4) immediately contacted the dental office and spoke with the dentist's assistant. - the dentist's assistant stated that the neck of the handpiece became extremely hot and burned a patient's lip. - no other information regarding the patient was available at this time. - (b)(4) contacted the dental office to obtain more information , and the nsk patient information form was immediately forwarded to the dental office to be completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2017-00026 |
| MDR Report Key | 6563159 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-05-12 |
| Date of Report | 2018-07-10 |
| Date of Event | 2017-04-07 |
| Date Facility Aware | 2017-04-13 |
| Report Date | 2017-04-22 |
| Date Reported to Mfgr | 2017-04-22 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2017-05-12 |
| 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 RP#9611253-2017-00026 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 | 2017-05-12 |
| Model Number | SGS-E2S |
| Catalog Number | H266001 |
| Operator | DENTIST |
| Device Availability | Y |
| 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 | 2017-05-12 |