FDA Adverse Event
Malfunction
Summary report: N
NSK TI-MAX X95L
MDR report key: 4269247
·
Received November 13, 2014
Report
- Report Number
- 9611253-2014-00030
- Event Type
- Malfunction
- Date Received
- November 13, 2014
- Date of Event
- October 15, 2014
- Report Date
- November 12, 2014
- Manufacturer
- NAKANISHI, INC. (NSK)
- Product Code
- EGS
- PMA / PMN Number
- K972569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
THE FOLLOWING INFORMATION IS FROM BRASSELER USA (B-USA) TO NAKANISHI, INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR B-USA. B-USA EVENT SUMMARY: PROCEDURE FILLING ON FACIAL #20, #21 LOWER BICUSPID, WATER WAS BEING SUPPLIED. DOCTOR NOTICED THE HANDPIECE HEATING FIRST, PATIENT UPPER LIP BURNED; BUT THERE WERE NO VISIBLE MARKS AND NO PERMANENT DAMAGE. NAKANISHI HAS REQUESTED ADDITIONAL INFORMATION FROM B-USA REGARDING THIS EVENT VIA WRITTEN LETTER SENT ON (B)(4)2014. B-USA DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 732897 | NSK TI-MAX X95L | HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL | EGS | NAKANISHI, INC. (NSK) | X95L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |