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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 E3KIT
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
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 results are not available as of this report.Evaluation results will be submitted as they become available.
 
Event Description
It was reported that an e3 motor was spinning too fast; no injury resulted.
 
Manufacturer Narrative
Main board failed the phase testing, (rpc3) and battery failed the charging cycle testing.(rba3).Parts need replaced.Repair, final testing and complete clean-up.Working time 9 hour 51 minutes.Charging cycles 61 started 36 finished.
 
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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 37604
MDR Report Key7775841
MDR Text Key117011277
Report Number2320721-2018-00091
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 10/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberE3KIT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Date Manufacturer Received09/20/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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