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

Model Number	Z45L
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The handpiece head overheated during a tooth extraction procedure on #3 and #31 teeth and the patient received a thermal burn injury to the inside of their cheek.There has been a follow-up visit with the patient at the office and the injury is reported to have healed normally without need for additional medical treatment.

• 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: 21692113
• Report Number: 1422375-2025-00003
• Device Sequence Number: 15807513
• Product Code: EGS
• UDI-Device Identifier: 04560264574083
• UDI-Public: 04560264574083
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2025
• Report Date (Section F): 03/13/2025

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: Z45L
• Device Catalogue Number: C1064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/06/2025
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2025
• 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: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: White