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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC E3 MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD
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TULSA DENTAL PRODUCTS LLC E3 MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number LNE3
Device Problems Mechanical Problem (1384); Device Remains Activated (1525)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received where this malfunction has caused file separation.Since separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.
 
Event Description
In this event it was reported that a e3 motor was running constantly; no injury resulted.
 
Manufacturer Narrative
Charged returned unit serial number (b)(6) overnight, unit would not calibrate "calibration abort" error.Unit also would not respond to foot pedal controls.Unit will be destroyed.Note: the covid-19 pandemic caused a disruption in normal business activities, resulting in late submission of this report.
 
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Brand Name
E3 MOTOR
Type of Device
CONTROLLER, FOOT, HANDPIECE AND CORD
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city, tn
MDR Report Key9827670
MDR Text Key191120201
Report Number2320721-2020-00034
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
PMA/PMN Number
K103653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLNE3
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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