MAUDE Adverse Event Report: NAKANISHI INC. ICARE; HANDPIECE MAINTENANCE SYSTEM

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
A dental assistant sustained an injury to their finger from an icare maintenance unit while performing the chuck maintenance on their handpiece 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.

• Brand Name: ICARE
• Common Device Name: HANDPIECE MAINTENANCE SYSTEM
• Manufacturer (Section D): NAKANISHI INC.; 700 shimohinata; kanuma-shi, tochigi-ken 322-8 666; JA 322-8666
• MDR Report Key: 25175281
• Report Number: 1422375-2026-00017
• Device Sequence Number: 18783402
• Product Code: EFB
• UDI-Device Identifier: 04560264538986
• UDI-Public: 04560264538986
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 05/14/2026
• Report Date (Section F): 05/01/2026

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: ICARE C2
• Device Catalogue Number: Y1002796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/16/2026
• Device Age: 11 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown