NSK
Report
- Report Number
- 9611253-2024-00026
- Event Type
- Injury
- Date Received
- May 27, 2024
- Date of Event
- April 26, 2024
- Report Date
- May 28, 2024
- Manufacturer
- NAKANISHI INC.
- Product Code
- EFB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
THIS EVENT OCCURRED IN JAPAN, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K112673. THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE PATIENT'S WEIGHT, GENDER, RACE, AND ETHNICITY. ACCORDING TO THE OEM, FURTHER INSPECTION OF THE HANDPIECE INVOLVED IN THE ADVERSE EVENT FOR CAUSE BY NAKANISHI IS NO LONGER POSSIBLE BECAUSE THE DENTIST REFUSED TO RETURN THE HANDPIECE TO NAKANISHI FOR THE INVESTIGATION. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI EXAMINED THE DEVICE HISTORY RECORD (DHR) FOR THE SUBJECT PERIO-HP SHO DEVICE SERIAL NO. (B)(6). AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.
ON (B)(6) 2024, NAKANISHI RECEIVED AN E-MAIL FROM AN OEM ABOUT A MALFUNCTION OF AN NSK HANDPIECE. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS: THE EVENT OCCURRED ON APRIL 26, 2024. THE DENTIST WAS CLEANING THE TEETH OF A PATIENT USING THE PERIO-HP SHO HANDPIECE (SERIAL NO. (B)(6) AND THE CLEANING POWDER. 1 TO 2 SECONDS AFTER THE PROCEDURE STARTED, THE PATIENT HAD AN ASTHMA ATTACK, AND THEIR BLOOD PRESSURE INCREASED, AND THEIR THROAT BECAME SWELLED UP. THE PATIENT WAS RUSHED TO THE HOSPITAL, WHERE THEIR SYMPTOMS IMPROVED BUT THE PATIENT WAS ADMITTED FOR FURTHER EXAMINATION. ACCORDING TO THE DENTIST, THE PATIENT HAS A MEDICAL HISTORY OF ASTHMA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 651782 | NSK | HANDPIECE, AIR-POWERED, DENTAL | EFB | NAKANISHI INC. | PERIO-HP SHO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Female | Other |