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U.S. Department of Health and Human Services

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

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LARES RESEARCH LARES 557 AIR DRIVEN HIGH-SPEED HANDPIECE Back to Search Results
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.
 
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Brand NameLARES 557
Type of DeviceAIR 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 Key6419329
MDR Text Key70422688
Report Number2916440-2017-00003
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K780038
Number of Events Reported1
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 Received03/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Dentist
Device Model Number557CX SWIVEL FIBER OPTIC
Device Catalogue Number10124-235
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2011
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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