MAUDE Adverse Event Report: NAKANISHI INC. NSK SGS; DENTAL HANDPIECE

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor was cutting a wisdom tooth when the attachment locked up and the patient received a burn injury to their tongue.No medical treatment was required at the time of the incident.The patient has not had a follow-up visit with the doctor at this time and the doctor has not received any report of complications or the need for further medical treatment from the patient as a result of the injury.

• Brand Name: NSK SGS
• Common Device Name: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 18999008
• Report Number: 1422375-2024-00009
• Device Sequence Number: 18209049
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 03/28/2024
• Report Date (Section F): 03/18/2024

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: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2024
• Device Age: 1 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• 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: 20 YR
• Patient Sex: Male
• Patient Weight: 91 KG