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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ASEPTICO ENDO DTC MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED
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TULSA DENTAL PRODUCTS LLC ASEPTICO ENDO DTC MOTOR; HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number AEU-25
Device Problem Mechanical Problem (1384)
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
It was reported that an aseptico dtc motor was not running at the correct speeds or torque; no injury resulted.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
ASEPTICO ENDO DTC MOTOR
Type of Device
HANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key7659750
MDR Text Key113288016
Report Number2320721-2018-00059
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
PMA/PMN Number
K030163
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 Received07/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAEU-25
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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