MAUDE Adverse Event Report: NAKANISHI INC. NSK; MICRO SURGERY HANDPIECE

Model Number SGS-E2S

Device Problem Temperature Problem (3022)

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

Event Date 05/07/2021

Event Type  Injury  

Event Description

Device overheated during a wisdom tooth extraction on tooth #32 and patient received a second degree burn to their lower right lip approximately 1cm in length and 1cm wide.Patient was under local anesthetic at the time of the injury.The injury is expected to heal normally and there has been no report of any further medical attention being required for treatment.

• Brand Name: NSK
• Type of Device: MICRO SURGERY HANDPIECE
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 12112020
• MDR Text Key: 264091330
• Report Number: 1422375-2021-00014
• 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: 07/02/2021,06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: H266001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Distributor Facility Aware Date: 06/08/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17 YR
• Patient Weight: 56