MAUDE Adverse Event Report: NAKANISHI INC. NSK; DENTAL HANDPIECE

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece overheated during a wisdom tooth extraction procedure and the patient received thermal burn injuries on both lower corners of their mouth.There was no medical treatment required at the time of the injury and the patient is believed to have healed normally without further medical treatment.

• Brand Name: NSK
• 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: 21972996
• Report Number: 1422375-2025-00005
• Device Sequence Number: 15752473
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• 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: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 05/06/2025
• Report Date (Section F): 04/22/2025

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: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/11/2025
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/22/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/06/2025
• 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: 16 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White