MAUDE Adverse Event Report: LARES RESEARCH LARES 557 AIR DRIVEN HIGH-SPEED HANDPIECE

Model Number 557CX SWIVEL FIBER OPTIC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4): original ship date 11/3/2011; serviced 9/5/2012 (replaced turbine), 10/25/2016 (replaced turbine), 2/10/2017 (replaced turbine). Chuck performance measures: release force - 11. 48 pounds; pull-out force 6. 20 pounds; static torque 3. 8 in-oz. Front spindle bore: 0. 06305 go, 0. 0632 no-go. Button to actuator clearance measured 0. 011 inches. No material of workmanship defects were identified in this product evaluation. Conclusion: the user did not seat dental bur fully in the chuck during use where the subsequent applied cutting loads dislodged the bur from the handpiece.

Event Description

(b)(6) called from dr. (b)(6)'s office and said the doctor was drilling a tooth on a patient and the bur fell out in the patient's mouth. The doctor was able to remove the bur quickly and without injury.

• Brand Name: LARES 557
• Type of Device: AIR DRIVEN HIGH-SPEED 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 ave; chico, CA 95973 ; 5303451767
• MDR Report Key: 6419329
• MDR Text Key: 70422688
• Report Number: 2916440-2017-00003
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780038
• 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: 03/20/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 557CX SWIVEL FIBER OPTIC
• Device Catalogue Number: 10124-235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2017
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/23/2011
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse