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 08/08/2022

Event Type  Injury  

Event Description

Handpiece overheated during a 3rd molar extraction procedure and patient received a notable superficial burn on their lower right lip.Patient was under iv sedation at the time of the injury.The burn was treated with bacitracin at the time of the event.Patient is reported to be healing normally without need for additional medical treatment.

• 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: 15402670
• MDR Text Key: 299697420
• Report Number: 1422375-2022-00035
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/31/2022,08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2022
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White