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	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece head overheated abnormally during a procedure and the patient received a thermal burn injury to the inside of their lip and cheek.The patient has had multiple follow-up appointments with the doctor and has complained of swelling at the burn site causing them to frequently bite their cheek.The injury is healing normally but the patient has reported numbness at the injury site.Patient information has not been provided at the time of this report and a follow-up report will be made if this information becomes available.

• 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: 25059791
• Report Number: 1422375-2026-00014
• Device Sequence Number: 9353743
• Product Code: EGS
• UDI-Device Identifier: 04560264575448
• UDI-Public: 04560264575448
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/01/2026
• Report Date (Section F): 05/01/2026

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: 04/02/2026
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2026
• 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: Male