MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-04 for NSK X-SG65L H1009 manufactured by Nakanishi Inc..
[141052330]
Nakanishi is still trying to obtain missing information about the patient.
Patient Sequence No: 1, Text Type: N, H10
[141052331]
On march 14, 2019, nakanishi received an e-mail from a distributor ((b)(4)) about a handpiece overheating. According to the distributor, one of the x-sg65l handpieces (serial no. (b)(4)) overheated and caused the following event, but the dentist could not identify which devices actually overheated. The details of the event are: the event occurred on (b)(6) 2019. The surgeon was removing the 3rd molar of the patient's lower right jaw using the x-sg65l handpiece. The patient was under anesthesia. During the procedure, the handpiece suddenly made an abnormal noise and stopped. The dentist noticed that oil had gotten onto his/her gloves and onto the patient's upper left lip. When removing the handpiece from the patient's mouth, there was a burn on the patient's lip. The surgeon immediately stopped the surgery, irrigated the wound and applied (b)(6) to the area. The surgical procedure was completed with another handpiece, as the handpiece involved in the event was no longer functioning. The surgeon reported that there was significant oil coming out of the handpiece when the device was cleaned by the staff later. The surgeon consulted other medical staff in the hospital, and the head of plastic surgery recommended kenalog in orobase. The hospital determined that no immediate burn treatment was necessary and that the hospital would conduct a follow-up with the patient. Nakanishi is submitting two separate mdrs for this event based on the information from the distributor. This mdr is regarding the handpiece with the serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2019-00022 |
| MDR Report Key | 8484698 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2017-09-06 |
| Date Added to Maude | 2019-04-04 |
| 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, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2019-04-04 |
| Returned To Mfg | 2019-03-20 |
| Model Number | X-SG65L |
| Catalog Number | H1009 |
| 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 | 2019-04-04 |