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

Model Number	Z95L
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Nsk america received a report of a patient thermal burn injury to the inside of their cheek from a nsk model z95l handpiece.The doctor did not observe any injury to the patient's inner cheek at the time of their treatment.The injury was reported by the patient to the doctor via phone call.The patient described having a round dime shaped lesion that was white in color on the inside of their cheek where the dental procedure was performed.From the patient's description the doctor believes the burn was caused by the handpiece push button back cap overheating during the procedure due to the shape and size of the burn description.The doctor did have a follow-up visit with the patient on (b)(6) 2026 and found that the reported injury had fully healed without need for further medical treatment.The doctor declined to provide patient information.

• Brand Name: TI-MAX Z
• 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: 24138034
• Report Number: 1422375-2026-00001
• Device Sequence Number: 18740489
• Product Code: EGS
• UDI-Device Identifier: 04560264575448
• UDI-Public: 04560264575448
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/20/2026
• Report Date (Section F): 01/08/2026

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: Z95L
• Device Catalogue Number: C1034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/22/2025
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2026
• 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 Sex: Unknown