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

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was reported to have received a slight burn to their inner cheek during a procedure.Attempts to obtain further information or detail on the event have been unsuccessful at this time and a follow up report will be made as more information becomes available.

• 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: 10624064
• Report Number: 1422375-2020-00015
• Device Sequence Number: 2604915
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 10/02/2020
• Report Date (Section F): 10/02/2020

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: SGS-E2S
• Device Catalogue Number: H266001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2020
• Device Age: 2 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/02/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/02/2020
• 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
• Date Report Sent to FDA: 10/02/2020