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	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was performing an extraction of 3rd molars with the patient under general anesthesia when blister the approximately the size of a pea was observed on the corner of patients right lower lip.Injury was cleaned and neosporin was administered to the area.Doctor has conducted a follow up with the patient and the injury has healed normally.No further medical treatment required for this injury.

• 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: 9868064
• Report Number: 1422375-2020-00005
• Device Sequence Number: 2910065
• Product Code: KMW
• UDI-Device Identifier: 04560264556287
• UDI-Public: 04560264556287
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2020
• Report Date (Section F): 03/23/2020

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: 03/18/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2020
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/23/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• 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: 17 YR
• Patient Weight: 59
• Date Report Sent to FDA: 03/23/2020