MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for NSK X-SG20L C1003 manufactured by Nakanishi Inc..
[124307104]
Nakanishi is now trying to obtain further information about the event including the patient information.
Patient Sequence No: 1, Text Type: N, H10
[124307105]
On (b)(6) 2018, nakanishi received an e-mail from a distributor ((b)(4)) about a patient's accidental ingestion of a spray pipe. Details are as follows: the event occurred on (b)(6) 2018. A dentist was performing a dental procedure using an x-sg20l handpiece (serial no. (b)(4)), which has an external water spray. During the procedure, the external spray pipe suddenly broke off and fell in the patient's mouth, and the patient swallowed the spray pipe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611253-2018-00047 |
| MDR Report Key | 7980243 |
| Date Received | 2018-10-18 |
| Date of Report | 2019-02-26 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2019-02-01 |
| Device Manufacturer Date | 2013-01-31 |
| Date Added to Maude | 2018-10-18 |
| 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 | 0 |
| Brand Name | NSK |
| Generic Name | HANDPIECE, ROTARY BONE CUTTING |
| Product Code | KMW |
| Date Received | 2018-10-18 |
| Model Number | X-SG20L |
| Catalog Number | C1003 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-10-18 |