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 07/17/2020

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 1422375-2022-00027.The dentist refused to provide the patient's age, weight, ethnicity, and race.Further information about the event, including information about the patient was not made available at this time.The handpiece involved in the adverse event would not be returned to the manufacturer for investigation.Nakanishi will submit a follow-up report to fda when further information and the device become available.

Event Description

On (b)(6) 2022, nakanishi became aware of a handpiece overheating through a complaint input into the complaint database by a distributor (nsk america).Details are as follows: the event occurred on (b)(6) 2020.The dentist was performing a dental procedure on a patient using the sgs-e2s handpiece (serial no.(b)(4)).During the procedure, the handpiece overheated, and the patient received a severe burn injury to their lip.The burn is noted to be 4x3x3 mm in size on the lower left lateral lip which resulted in a residual scar.The patient has reported to continue to experience pain and numbness at the site of the injury.

• 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: 15024227
• MDR Text Key: 295952486
• Report Number: 9611253-2022-00049
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: SGS-E2S
• Device Catalogue Number: H266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 9611253-060818-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female