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 08/27/2021

Event Type  Injury  

Event Description

Device overheated during a wisdom tooth extraction procedure and patient received a second degree burn injury to their lower lip.Patient is reported to have healed normally without any need for additional medical treatment.

Event Description

Correction of device model number and catalog number.

• 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: 12550665
• MDR Text Key: 274024394
• Report Number: 1422375-2021-00024
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 09/29/2021,09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• 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: 09/10/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Distributor Facility Aware Date: 09/01/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 52