NSK
Received Jul 15, 2026 · Event occurred May 19, 2026
Report 9611253-2026-00037 · MDR key 25834405
Device
Generic name
Handpiece, Rotary Bone Cutting
Manufacturer
Nakanishi Inc.Model number
SGA-E2SCatalog number
H265
Product problems
- Overheating of Device
Patient
NA · Unknown
- Partial thickness (Second Degree) Burn
Narrative
Description of Event or Problem
ON JUNE 23, 2026, NAKANISHI BECAME AWARE OF HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (B)(4). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON MAY 19, 2026. THE DENTIST WAS PERFORMING A THIRD MOLAR EXTRACTION PROCEDURE ON A PATIENT USING THE SGA-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.
Additional Manufacturer Narrative
THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE PATIENT.
Remedial action
- Recall