InjuryKMW

SGA-E2S

Received Jul 7, 2026 · Event occurred May 19, 2026

Report 1422375-2026-00026 · MDR key 25739979

Device

Generic name

Dental Handpiece

Manufacturer

Nakanishi Inc.

Model number

SGA-E2S

Catalog number

H265

Product problems

Overheating of Device

Patient

NA · Unknown

Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

THE DOCTOR HAD THEIR SGA-E2S HANDPIECE OVERHEAT UNEXPECTEDLY DURING A THIRD MOLAR EXTRACTION 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.