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

Model Number	SGA-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	08/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received a superficial burn to their lip during apicoectomy procedure on number 19 tooth.Patient was under deep sedation at the time of the event.Antibiotic ointment was applied to the burn.The patient is reported to be healing normally with no complications or need for further medical treatment.

• Brand Name: NSK
• 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: 10577461
• Report Number: 1422375-2020-00014
• Device Sequence Number: 16928661
• Product Code: KMW
• UDI-Device Identifier: 04560264556287
• UDI-Public: 04560264556287
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/23/2020
• Report Date (Section F): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Distributor Facility Aware Date: 08/28/2020
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2020
• 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: 60 YR
• Patient Weight: 86