MAUDE Adverse Event Report: LARES RESEARCH PRECISION-TORQUE PUSH BUTTON; AIR DRIVEN DENTAL HANDPIECE

Model Number 557

Device Problem Temperature Problem (3022)

Patient Problem Burn, Thermal (2530)

Event Date 07/24/2014

Event Type  Other  

Event Description

Customer/end user described the dental handpiece device would get hot during use and two unk pt's cheeks were burned.Three devices were returned for eval.

Manufacturer Narrative

Three devices were returned for eval.Serial number (b)(4): handpiece manufacture date 04/2014; no problems or defects identified.Serial number (b)(4): handpiece manufacture date 04/01/2014; no problem of defects identified.Serial number (b)(4): handpiece manufacture date 04/2014; push button chuck manufacture date code 03/14.Returned handpiece was functional as returned to lares.Visual eval identified that the head cap assembly was deformed due to impact and was out of position.This prevented the push button from seating squarely in the head cap.The intermittent tilt stick of the button reduced the internal chuck spring to button retaining crown clearance.A small amount of dynamic contact marking was visible on one of the four button retention crown features and on one of the push button chuck springs.The intermittent dynamic contact may have generated frictional heat in the head of the handpiece as reported by the user.Conclusion: based on the one returned product condition, the heating of the handpiece was due to damage sustained by the handpiece head cap and subsequent intermittent push button dynamic contact with the push button chuck springs.No handpiece material or workmanship defects were identified.

• Brand Name: PRECISION-TORQUE PUSH BUTTON
• Type of Device: AIR DRIVEN DENTAL HANDPIECE
• Manufacturer (Section D): LARES RESEARCH; chico CA
• Manufacturer Contact: jason orgain ; 295 lockheed ave.; chico, CA 95973 ; 5303451767
• MDR Report Key: 4170737
• MDR Text Key: 18733727
• Report Number: 2916440-2014-00001
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 557
• Device Catalogue Number: 10064
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2014
• Initial Date FDA Received: 09/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Patient Outcome(s): Other