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

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece overheated during a procedure and the patient received a thermal burn injury to their lip.The injury was treated by the doctor in the office at the time of the incident.The patient has had a follow-up visit with the doctor since the incident and the injury has healed normally without need for additional medical treatment.(b)(6) has been unable to obtain the date of the incident or the patients information from the dental practice.

• Brand Name: NSK SGS
• 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: 21518973
• Report Number: 1422375-2025-00002
• Device Sequence Number: 13151744
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/27/2025
• Report Date (Section F): 02/10/2025

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: 02/11/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2025
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2025
• 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 Sex: Unknown