NSK
Received Jul 15, 2026 · Event occurred Jun 9, 2026
Report 9611253-2026-00038 · MDR key 25834416
Device
Generic name
Handpiece, Rotary Bone Cutting
Manufacturer
Nakanishi Inc.Model number
SGS-E2SCatalog number
H266
Product problems
- Overheating of Device
Patient
18 YR · Male
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE PATIENT'S WEIGHT, ETHNICITY AND RACE.
Description of Event or Problem
ON JUNE 23, 2026, (B)(6) BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON JUNE 9, 2026. - THE DENTIST WAS PERFORMING A THIRD MOLAR SURGERY ON A PATIENT USING THE SGS-E2S HANDPIECE (SERIAL NO. (B)(6). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED UNEXPECTEDLY, AND THE PATIENT RECEIVED A THERMAL BURN INJURY TO THEIR LIP. - THE PATIENT'S INJURY WAS TREATED AT THE TIME OF THE INCIDENT WITHOUT NEED FOR ADDITIONAL TREATMENT.
Remedial action
- Recall