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	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece head overheated abnormally during a filling procedure on teeth numbers 3, 4, 5, 28, 30, and the patient received a thermal burn injury to their inner cheek mucosa.No medical treatment was required the time of the injury.The patient has had a follow up visit after the incident and is reported to have healed normally without need for additional medical treatment.The end-user 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: 24943666
• Report Number: 1422375-2026-00011
• Device Sequence Number: 5585612
• Product Code: EGS
• UDI-Device Identifier: 04560264575448
• UDI-Public: 04560264575448
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/21/2026
• Report Date (Section F): 04/09/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2026
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/23/2026
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2026
• 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