MAUDE Adverse Event Report: NAKANISHI INC. SGA-E2S; DENTAL HANDPIECE

Model Number	SGA-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an extraction of the patient's third molar the sga-e2s 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.

• Brand Name: SGA-E2S
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 25739980
• Report Number: 1422375-2026-00024
• Device Sequence Number: 10645485
• Product Code: KMW
• UDI-Device Identifier: 04560264556287
• UDI-Public: 04560264556287
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/07/2026
• Report Date (Section F): 06/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2026
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/09/2026
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female