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

Model Number X85L

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/15/2023

Event Type  Injury  

Event Description

The handpiece head and back cap overheated during a crown preparation procedure and the patient received a minor burn injury to the inside of their cheek.No medical treatment was necessary for the injury at the time of the event.The patient has had a follow-up visit with the doctor and the injury was reported to have healed normally without need for any additional medical treatment.

• Brand Name: TI-MAX X
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 18302871
• MDR Text Key: 330183790
• Report Number: 1422375-2023-00027
• Device Sequence Number: 1
• Product Code: EGS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X85L
• Device Catalogue Number: C604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/21/2023
• Device Age: 10 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White