MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, ROTARY BONE CUTTING

Model Number SGS-E2S

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

The same adverse event in this report has been reported to the fda separately by the distributor, nsk america corporation, under report number 1422375-2024-00008.The dentist refused to provide any information about the patient.

Event Description

On march 9, 2024, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor (nsk america).According to the distributor, there are three devices suspected to be involved in the event, but the dentist could not identify which one of the devices actually caused the following event.Therefore, nakanishi is submitting three separate mdrs for this event.This mdr is regarding the handpiece with the serial number (b)(6).Details are as follows: - the event occurred on january 16, 2024.- the dentist was performing a surgical third molar extraction procedure on a patient using the sgs-e2s handpiece (serial no.(b)(6) ).- during the procedure, the surgical handpiece overheated, and the patient received a second degree burn to their lip.- the 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 dentist has not been made aware of the need for additional medical treatment or complications from the injury since the incident.

• Brand Name: NSK
• Type of Device: HANDPIECE, ROTARY BONE CUTTING
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer (Section G): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• Manufacturer Contact: sean kaufman ; 1800 global parkway; hoffman estates, IL 60192 ; 2245128921
• MDR Report Key: 18995390
• MDR Text Key: 338886552
• Report Number: 9611253-2024-00017
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Date Manufacturer Received: 03/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other