MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-08-08 for NSK SGA-E2S H265 manufactured by Nakanishi Inc..
[51341181]
Since the patient weight was not included in the information about the adverse event, nakanishi received from the distributor on june 19, 2016, nakanishi sent the distributor an email for the information about the patient weight on (b)(6) 2016. According to the distributor, the dentist refused to provide the information. Due to the device not being returned from the distributor, an examination of the dhr for device (h265 sga-e2s 1:2 20 degree angle, serial no. (b)(4)) is the only investigation approach nakanishi inc. , (b)(4) (manufacturer) can make. As a result of the examination, the dhr indicated that no problems had occurred during manufacturing and testing of the subject device.
Patient Sequence No: 1, Text Type: N, H10
[51341182]
On june 19, 2016, nakanishi received an email from a distributor ((b)(4)) stating that a patient was burned due to a handpiece overheating. Details are as follows. The event occurred on (b)(6) 2016. The dentist was sectioning a tooth during the extraction of wisdom teeth. The dentist was aware of the unit overheating during the procedure and found the handpiece had burned the inside of the patient's mouth. According to the dentist, the damage is a possible 2nd degree burn. The dentist applied burn ointment to the burn injury in the patient's mouth. When the patient visited the dental office on (b)(6) 2016, the dentist confirmed that the injury was still healing and was not expected to leave any permanent damage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2016-00040 |
| MDR Report Key | 5852921 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-08-08 |
| Date of Report | 2018-07-10 |
| Date of Event | 2016-06-17 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2012-02-29 |
| Date Added to Maude | 2016-08-08 |
| 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. |
| Manufacturer Street | 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 | 2016-08-08 |
| Model Number | SGA-E2S |
| Catalog Number | H265 |
| Operator | DENTIST |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-08-08 |