MAUDE Adverse Event Report: NAKANISHI INC. SGS-E2S; DENTAL HANDPIECE

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

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

Event Date 01/16/2024

Event Type  Injury  

Event Description

During a surgical third molar extraction procedure the handpiece overheated, and the patient received a second degree burn to their lip.Patient was treated for the burn injury in the er at the time of the incident and was recommended to follow up with the burn center if necessary.The end-user has not been made aware of the need for additional medical treatment or complications from the injury since the incident.The end-user was not able to identify the handpiece serial number involved in the incident but is one of three they have at the location.Since the specific handpiece serial number cannot be identified, three reports will be made.[this is report 1 of 3, please see mdr 2024-00007, 2024-00008 for specific device information].

• Brand Name: SGS-E2S
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma, tochigi 322-8 666; JA 322-8666
• MDR Report Key: 18871545
• MDR Text Key: 337293128
• Report Number: 1422375-2024-00006
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• 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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2024
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other