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

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/17/2020

Event Type  Injury  

Event Description

Nsk america was made aware of a patient burn injury that had occurred in (b)(6) of 2020.Patient is reported to have received a severe burn injury to their lip.The burn is noted to be 4x3x3 mm in size on the lower left lateral lip which resulted in a residual scar.Patient has reported to continue to experience pain and numbness at the site of the injury.Further information was not made available at this time.A follow up report will be made if further information becomes available.

• Brand Name: NSK
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 15008786
• MDR Text Key: 295861179
• Report Number: 1422375-2022-00027
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022,06/21/2022

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
• Device Operator: Health Professional
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/21/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female