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

Model Number	SGA-E2S
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dentist refused to provide information about the patient's weight.
Event or Problem Description
On march 25, 2026, 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) 2026.- the dentist was performing an extraction and bone graft procedure on #2 and #15 teeth of a patient using the sga-e2s handpiece (serial no.(b)(6)).- during the procedure, the handpiece overheated, and the patient received a thermal burn injury to their lower left lip and chin approximately 1 inch in length.- due to the external location of the injury site the patient consulted with a dermatologist and although the wound is healing normally, the patient may be left with a permanent visible scar that may require plastic surgery to minimize its appearance.

• Brand Name: NSK
• Common Device Name: 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: 24906308
• Report Number: 9611253-2026-00016
• Device Sequence Number: 15934747
• Product Code: KMW
• UDI-Device Identifier: 04560264556287
• UDI-Public: (01)04560264556287
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SGA-E2S
• Device Catalogue Number: H265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 9611253-060818-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White