MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-01-17 for NSK Z95L C1034 manufactured by Nakanishi Inc..
[188811348]
Nakanishi did not receive the patient's age or weight, but is scheduled to visit the dentist to obtain the information.
Patient Sequence No: 1, Text Type: N, H10
[188811349]
On december 25, 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 performing a crown removal on a patient using the z95l handpiece (serial no. (b)(4)). During the procedure, the handpiece overheated and burned the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2020-00002 |
| MDR Report Key | 9599623 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2020-01-17 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2014-09-23 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2020-01-17 |
| Returned To Mfg | 2019-12-26 |
| 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, 322-8666 JA 322-8666 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-17 |