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

Model Number SMOOTHDRIVE

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 04/10/2024

Event Type  malfunction  

Manufacturer Narrative

The device was evauated and the damage was too severe to identfify a root cause of the bearing failure.

Event Description

Customer sent product in for repair with note indicating a patient had been burned by the device during a procedure.The patient was treated at the dental office and did not require additional medical intervention.

• Brand Name: SMOOTHDRIVE
• Type of Device: 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: 19098225
• MDR Text Key: 340807206
• Report Number: 2916440-2024-00005
• Device Sequence Number: 1
• Product Code: EGS
• UDI-Device Identifier: D950135020
• UDI-Public: D950135020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/12/2024

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
• Device Operator: Health Professional
• Device Model Number: SMOOTHDRIVE
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other