MAUDE Adverse Event Report: LARES RESEARCH SMOOTHDRIVE; CONTRA ANGLE HANDPIECE

Model Number	1:5 CA
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Was operating handpiece during procedure when a hot head cap was identified.A burn was then noted on patient's lip.
Additional Manufacturer Narrative
Customer is returning the unit but it has not arrived yet.A followup report will be issued once the device has been received and evaluated.
Additional Manufacturer Narrative
The device was sent back to the factory and evaluated by engineering.The device had a significant wear mark on the head cap button indicating it had contacted the head gear cartridge chuck actuator when it was operating.This can happen if the operator uses the head of the device as a cheek retractor which depresses the head cap button and contacts the rotating actuator and quickly gets very hot.The device ifu clearly cautions the user about this hazard.
Event or Problem Description
Dr.Was operating handpiece during procedure when a hot head cap was identified.A burn was then noted on patient's lip.

• Brand Name: SMOOTHDRIVE
• Common Device Name: CONTRA ANGLE HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer (Section G): LARES RESEARCH; 295 lockheed avenue; chico CA 95973
• Manufacturer Contact: bruce holderbein ; 295 lockheed avenue; chico, CA 95973 ; 5303451767
• MDR Report Key: 21845076
• Report Number: 2916440-2025-00003
• Device Sequence Number: 9281233
• Product Code: EGS
• UDI-Device Identifier: D950135020
• UDI-Public: D950135020
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K220874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1:5 CA
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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
• Patient Sex: Unknown