MAUDE Adverse Event Report: NAKANISHI INC. SGA; 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	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The subject handpiece overheated during an extraction and bone graft procedure on #2 and #15 teeth and the patient received a thermal burn injury to their lower left lip and chin approximately 1 inch in length.Due to the external location of the injury site the patient consulted with a dermatologist and although the wound is healing normally, the patient may be left with a permanent visible scar that may require plastic surgery to minimize its appearance.

• Brand Name: SGA
• 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: 24692578
• Report Number: 1422375-2026-00009
• Device Sequence Number: 18573659
• Product Code: KMW
• UDI-Device Identifier: 04560264556287
• UDI-Public: 04560264556287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/25/2026
• Report Date (Section F): 03/24/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2026
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• 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: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White