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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 Problems Break (1069); Mechanical Problem (1384); Defective Device (2588)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
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
It was reported that an e3 motor stalled during use and caused a file to break in a patient's tooth.
 
Manufacturer Narrative
Found unit to have no activation, open motor cable and worn motor cartridge.Needs new motor assembly, battery will be fine.
 
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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 Key8233426
MDR Text Key133860654
Report Number2320721-2018-00216
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 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
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? Yes
Date Manufacturer Received03/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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