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	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The nsk model z95l handpiece overheated abnormally during a crown preparation procedure and the patient received a thermal burn injury to their lower lip on the right side.The patient has had a follow up with the doctor since the incident and is believed to have healed normally without any reported need for additional medical treatment for the injury.

• 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: 23407989
• Report Number: 1422375-2025-00022
• Device Sequence Number: 8890890
• Product Code: EGS
• UDI-Device Identifier: 04560264575448
• UDI-Public: 04560264575448
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 10/28/2025
• Report Date (Section F): 10/07/2025

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: Z95L
• Device Catalogue Number: C1034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2025
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2025
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2025
• 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: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White