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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD
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TULSA DENTAL PRODUCTS LLC X-SMART IQ MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD Back to Search Results
Catalog Number H105900000000
Device Problems Mechanical Problem (1384); Power Conditioning Problem (1474)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 the speed of the x-smart iq was too slow.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
X-SMART IQ 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 Key9533794
MDR Text Key178622411
Report Number8031010-2019-00281
Device Sequence Number1
Product Code EBW
Combination Product (y/n)N
PMA/PMN Number
K161213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberH105900000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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