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 07/13/2022

Event Type  Injury  

Event Description

Handpiece overheated during an extraction procedure for tooth #17 and tooth #32, patient sustained a small burn to their lower lip.The patient is reported to have healed normally without any 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: 15219054
• MDR Text Key: 297807418
• Report Number: 1422375-2022-00032
• 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: 08/08/2022,07/14/2022

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: 07/14/2022
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American