MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-02-10 for NSK SGS-E2S H266 manufactured by Nakanishi Inc..
[38045879]
On (b)(6) 2016, nakanishi received a phone call from a distributor about an nsk dental product. Details are as follows. On (b)(6) 2016, a dentist was cutting a bone of a patient to extract a wisdom tooth using nsk surgical handpiece, sgs-e2s. The patient was under general anesthesia. A burn injury (2. 0 centimeters by 0. 5 centimeters) was observed on the patient's oral mucosa membrane. The dentist did not feel heat at the handpiece grip where he was holding, but felt heat at the tip of the handpiece. The dentist decided to give the patient follow-up observations instead of medications.
Patient Sequence No: 1, Text Type: D, B5
[46371995]
Upon receipt from a distributor of the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [c160126-07-1]. Methodology used : nakanishi examined the device history record including repair records for the subject sgs-e2s device [serial number (b)(4). ]. There were no problems observed during the manufacturing or testing noted in the dhr. Nakanishi then rotated the handpiece and observed that the handpiece did not rotate at all. Nakanishi disassembled the handpiece and performed a visual inspection of the inside parts. Nakanishi observed as follows : bearing (1) : abrasion, bearing (2) : breakage, abrasion mark in the inner race of the bearing, bearing (3) : dirt/discoloration, gear : discoloration, nakanishi took photographs of all the disassembled parts and kept them in a file. Conclusions reached based on the investigation and analysis results : nakanishi identified that the cause of overheating of the returned device was due to the bearings broken by dirt ingress. A lack of maintenance causes the above situation, which will contribute to the handpiece overheating. After replacing the broken bearings with the new bearings, nakanishi confirmed that the handpiece rotated normally and did not overheated. Nakanishi took the following actions in order to prevent a recurrence of the handpiece overheating. Nakanishi reviewed the operation manual and reconfirmed clarity and understandability of the instructions. Nakanishi reported the above evaluation results to the dentist and reminded the dentist of the importance of maintenance and checking of the handpiece prior to use to prevent overheating as instructed in the operation manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611253-2016-00006 |
| MDR Report Key | 5426874 |
| Report Source | FOREIGN |
| Date Received | 2016-02-10 |
| Date of Report | 2018-07-10 |
| Date of Event | 2015-12-14 |
| Date Mfgr Received | 2018-06-09 |
| Device Manufacturer Date | 2010-10-07 |
| Date Added to Maude | 2016-02-10 |
| 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. |
| 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 | 2016-02-10 |
| Returned To Mfg | 2016-01-26 |
| Model Number | SGS-E2S |
| Catalog Number | H266 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-02-10 |