MAUDE Adverse Event Report: Nakanishi Inc. Ti-Max X; Dental Handpiece

Model Number	X450 M4
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient experienced postoperative swelling following a dental procedure consistent with air entering the tissue.The office could not determine which of three handpieces they have was used during the procedure but removed all three from service after observing air blowing outward from each unit.The swelling experienced by the patient resolved with ice before discharge, and follow-up confirmed there were no lasting complications or need for additional medical treatment.This is report 3 of 3 for this issue.(reference mdr 2026-00028, 2026-00029 for previous reports).

• Brand Name: Ti-Max X
• 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: 50047252
• Report Number: 1422375-2026-00030
• Device Sequence Number: 10627875
• Product Code: EFB
• UDI-Device Identifier: 04560264572645
• UDI-Public: 04560264572645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/27/2026
• Report Date (Section F): 07/27/2026

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: X450 M4
• Device Catalogue Number: P1092
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2026
• Device Age: 6 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/27/2026
• 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