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

Model Number SGA-E2S

Device Problem Overheating of Device (1437)

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

Event Date 12/08/2021

Event Type  Injury  

Event Description

Device overheated and patient received a burn injury to their left lower lip and chin.Patient was under local anesthesia at the time of the injury and no medical treatment was necessary.Patient is reported to be healing normally without need for any 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: 13053030
• MDR Text Key: 282567554
• Report Number: 1422375-2021-00035
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 12/21/2021,12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2021
• Distributor Facility Aware Date: 12/08/2021
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White