MAUDE Adverse Event Report: NAKANISHI INC. NSK; HANDPIECE, AIR-POWERED, DENTAL

Model Number	ICARE C2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, nakanishi became aware of dental assistant injury caused by a handpiece maintenance unit through a complaint input into the complaint database by a distributor (nsk america).The details nakanishi obtained are as follows: the event occurred on (b)(6) 2026.A dental assistant was performing the chuck maintenance on their handpiece using the icare handpiece maintenance unit (serial no.(b)(6)) before reprocessing.The assistant was lubricating the handpiece chuck using the chuck lubrication nozzle included with the icare when the nozzle shot off the connector unexpectedly and the tip of the nozzle punctured the assistant's finger.The dental assistant is reported to have healed from the injury without need for any additional medical treatment.
Additional Manufacturer Narrative
The dental clinic declined to provide information about the dental assistant.

• Brand Name: NSK
• Common Device Name: HANDPIECE, AIR-POWERED, DENTAL
• 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: 25311162
• Report Number: 9611253-2026-00024
• Device Sequence Number: 18775432
• Product Code: EFB
• UDI-Device Identifier: 04560264538986
• UDI-Public: (01)04560264538986
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K081811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: ICARE C2
• Device Catalogue Number: Y1002796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/24/2015
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown