NSK

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 26, 2026. THE DENTIST WAS PERFORMING AN EXTRACTION OF THE PATIENT'S THIRD MOLAR 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 ANY REPORTED NEED FOR ADDITIONAL TREATMENT. THE PATIENT HAS NOT HAD A FOLLOW UP WITH THE DOCTOR SINCE THE INCIDENT BUT IS BELIEVED TO HAVE HEALED NORMALLY.

Additional Manufacturer Narrative

THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE PATIENT'S WEIGHT, ETHNICITY AND RACE.