MAUDE Adverse Event Report: LARES RESEARCH LARES RESEARCH; HIGH-SPEED DENTAL HANDPIECE

Model Number	757 PROSTYLE SF
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Dr sent in device with note that a bur had come out during procedure.The bur was not swallowed by the paitent.
Additional Manufacturer Narrative
The device was not well maintained and there was significant debris in the chucking mechanism which caused premature wear.

• Brand Name: LARES RESEARCH
• Common Device Name: HIGH-SPEED DENTAL 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: 17664696
• Report Number: 2916440-2023-00014
• Device Sequence Number: 6208152
• Product Code: EFB
• UDI-Device Identifier: D950131412220
• UDI-Public: D950131412220
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 757 PROSTYLE SF
• Device Catalogue Number: 13141-222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• 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