MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-08 for NSK Z95L C1034 manufactured by Nakanishi Inc..
[187393233]
Nakanishi did not receive detailed information on the event, including information about the patient. Nakanishi is scheduled to visit the dentist to obtain the information. Upon receiving the device involved in the mdr event, nakanishi conducted a failure analysis of the returned device [(b)(4)]. These activities are described in more detail below. Methodology used: nakanishi examined the device history record and the repair history for the subject z95l device [serial no. (b)(4)]. There were no problems observed during the manufacturing or testing noted in the dhr. There were also no repair history records since the device was shipped. Nakanishi set a test bur in the handpiece, connected the handpiece to the motor and tried to rotate the motor. However, the handpiece was locked, and the motor did not rotate at all. Therefore, nakanishi was not able to conduct temperature testing of the device. Identification of the specific failure mode(s) and/or mechanism(s) of the associated device components was conducted as follows: nakanishi disassembled the handpiece and performed a visual inspection of the internal parts. Nakanishi observed the following phenomena: the ball bearing on the rear side of the cartridge was broken. There was debris on the other parts. Nakanishi took photographs of all of the disassembled parts and kept them in investigation report (b)(4). Conclusions reached based on the investigation and analysis results: nakanishi identified that the cause of the overheating of the returned device was abnormal resistance during rotation due to the broken ball bearing. Nakanishi considers the possibility from many years of experience that the cause of the broken ball bearing was the ingress of undesirable materials into the bearing. A lack of maintenance caused the accumulation of debris on the internal parts, which caused debris ingress into the bearing during rotation. This contributed to the handpiece overheating. In order to prevent a recurrence of the handpiece overheating, nakanishi took the following actions: nakanishi reviewed the operation manual and reconfirmed the clarity and understandability of the instructions. Nakanishi will report the above evaluation results to the dentist, and remind the dentist of the importance of maintenance, as instructed in the operation manual.
Patient Sequence No: 1, Text Type: N, H10
[187393234]
On december 18, 2019, nakanishi received a phone call from a dealer about an nsk handpiece overheating. The information nakanishi obtained from the communication is as follows: the event occurred on (b)(6) 2019. A dentist was cutting the patient's jawbone using the z95l handpiece (serial no. (b)(4)). During the procedure, the handpiece head overheated and burned the mucosa of the patient's left cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2020-00001 |
| MDR Report Key | 9567278 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-08 |
| Date of Report | 2020-02-14 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2017-02-09 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL |
| Product Code | EGS |
| Date Received | 2020-01-08 |
| Returned To Mfg | 2019-12-18 |
| Model Number | Z95L |
| Catalog Number | C1034 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-08 |