MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-07 for NSK SGS-E2S H266 manufactured by Nakanishi Inc..
[129751680]
(b)(4). According to the distributor, the dentist refused to provide the patient's age and weight.
Patient Sequence No: 1, Text Type: N, H10
[129751681]
On (b)(6) 2018, nakanishi received an e-mail from a (b)(4) about a handpiece overheating. Details are as follows. The event occurred on (b)(6) 2018. The dentist was performing a surgical extraction of #3 on patient using the sgs-e2s handpiece (serial no. (b)(4)). The patient was under local anesthesia. While sectioning the tooth in the surgical extraction, the dentist removed the handpiece from the patient's mouth and became aware of a second degree burn on the lower right-side lip. The burn was circular in shape and approximately 8mm by 12mm in size. The dentist applied cool gauze to the burn and neosporin to the exterior of the lip. There were no abnormalities in the device observed prior to use. The dentist has followed up with the patient and observed the burn was healing normally. The dentist determined that no further medical attention was required for the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2018-00063 |
| MDR Report Key | 8144442 |
| Date Received | 2018-12-07 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-11-02 |
| Date Facility Aware | 2018-11-14 |
| Report Date | 2018-11-16 |
| Date Reported to Mfgr | 2018-11-16 |
| Date Mfgr Received | 2018-12-18 |
| Device Manufacturer Date | 2016-08-10 |
| Date Added to Maude | 2018-12-07 |
| 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# : 9611253-2018-00063 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 | 0 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2018-12-07 |
| Model Number | SGS-E2S |
| Catalog Number | H266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 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 | 2018-12-07 |