MAUDE Adverse Event Report: NAKANISHI INC. TI-MAX X; DENTAL HANDPIECE

Model Number	X95L
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	04/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During a crown preparation on tooth #18 the head of the handpiece became very hot resulting in a thermal burn injury to the right side of the patient's tongue.There has not been any follow-up with the patient since the incident, and it is unknown if there was need for additional medical treatment because of the injury.The patient has been unresponsive to any of practices attempts for a follow-up examination or obtaining information on the status of their injury.The dental practice is unsure of which handpiece was involved in the incident out of the two handpieces they have identified as suspect devices.Both devices are being reported separately for the same adverse event.This is report 1 of 2.[reference mdr 2026-00021 for the second suspect device information].

• Brand Name: TI-MAX X
• 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: 25490890
• Report Number: 1422375-2026-00020
• Device Sequence Number: 9735633
• Product Code: EGS
• UDI-Device Identifier: 04560264565845
• UDI-Public: 04560264565845
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/12/2026
• Report Date (Section F): 05/19/2026

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: X95L
• Device Catalogue Number: C600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2026
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/19/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2026
• 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: 68 YR
• Patient Sex: Female