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U.S. Department of Health and Human Services

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

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LARES RESEARCH SMOOTHDRIVE; HIGH-SPEED CONTRA ANGLE HANDPIECE Back to Search Results
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.
 
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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 Key19085324
MDR Text Key340682195
Report Number2916440-2024-00003
Device Sequence Number1
Product Code EGS
UDI-Device IdentifierD950135020
UDI-PublicD950135020
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220874
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 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 Number1:5 CA
Device Catalogue Number13502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/10/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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