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

Model Number	SGS-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019 the doctor was performing a wisdom tooth extraction on #17 with the patient under local anesthesia when the handpiece he was using heated up and caused a burn to the patient's lip.The doctor prescribed medrol dosepak for treatment of the injury.The doctor has had a follow up with the patient and the injury is healing normally.No further medical treatment was reported to be required for treatment.

• Brand Name: NSK
• Common Device Name: SURGICAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, 322-8 666; JA 322-8666
• MDR Report Key: 9358998
• Report Number: 1422375-2019-00020
• Device Sequence Number: 13573006
• Product Code: KMW
• UDI-Device Identifier: 04560264556294
• UDI-Public: 04560264556294
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 11/21/2019
• Report Date (Section F): 11/21/2019

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?: No
• Operator of Device: Health Professional
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/01/2019
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2019
• 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 Weight: 68
• Date Report Sent to FDA: 11/21/2019