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

Model Number 1:5 CA

Device Problem Mechanical Problem (1384)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

The device was tested at the manufacturer service depot and all performance measures meet new specifications.No material or manufacturing defects were noted.

Event Description

The customer indicated a bur came out of the handpiece during a procedure.The bur was retrieved and the patient was not affected.

• Brand Name: SMOOTHDRIVE
• Type of Device: HIGH-SPEED 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: 19085324
• MDR Text Key: 340682195
• Report Number: 2916440-2024-00003
• 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
• Type of Report: Initial
• Report Date: 04/09/2024

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
• Device Operator: Health Professional
• Device Model Number: 1:5 CA
• Device Catalogue Number: 13502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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