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

Model Number SMOOTHDRIVE 1:5 CA

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

Device was tested by the manufacturer and operated as intended.The customer was operating the device without cooling water when the device became hot.

Event Description

Device became warm when doctor was performning dental procedure.

• Brand Name: LARES RESEARCH
• 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: 16678762
• MDR Text Key: 312769675
• Report Number: 2916440-2023-00007
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SMOOTHDRIVE 1:5 CA
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1