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

Model Number 557

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 02/14/2022

Event Type  malfunction  

Manufacturer Narrative

Dr.Sent in several handpieces for review by engineering.Two of the four handpieces sent back to the factory had chucking systems which met the factory specifications, but were at higher end of acceptance testing for release force to remove burs.The turbines were replaced and the handpieces were returned to the doctor.The doctor was contacted by lares research to communicate the necessity to completely insert burs for each procedure.

Event Description

Dr.Called and indicated two incidents of burs coming out of handpieces.Dr.Indicated no patients were injured.Dr.Also indicated having difficulty inserting burs.

• Brand Name: LARES RESEARCH
• Type of Device: 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: 13713489
• MDR Text Key: 296960294
• Report Number: 2916440-2022-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141221
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 557
• Device Catalogue Number: 13124-222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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