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

Model Number	NANO95LS
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that they ran the handpiece outside of the patient's mouth to make sure water and light comes on.Within a few seconds of working on the tooth the patient reacted in pain.The doctor asked the patient if the tooth was numb and they stated it was fine, so the doctor proceeded with the preparation of the tooth for the crown.Once the doctor removed the handpiece from the patient's mouth to change burs, the doctor noticed the head of the handpiece was extremely hot to the touch.This is when the doctor observed that the patient's buccal mucosa had been burned.

• 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: 23032289
• Report Number: 1422375-2025-00014
• Device Sequence Number: 9820582
• Product Code: EGS
• UDI-Device Identifier: 04560264566002
• UDI-Public: 04560264566002
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 09/11/2025
• Report Date (Section F): 08/18/2025

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: NANO95LS
• Device Catalogue Number: C1099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2025
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2025
• 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: 56 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian