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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC ASEPTICO 10K TORQUE CONTROL MOTOR; UNIT, OPERATIVE DENTAL
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TULSA DENTAL PRODUCTS LLC ASEPTICO 10K TORQUE CONTROL MOTOR; UNIT, OPERATIVE DENTAL Back to Search Results
Catalog Number AM8B
Device Problems Retraction Problem (1536); Inappropriate or Unexpected Reset (2959)
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 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 10k torque control motor was improperly auto-reversing; no injury resulted.
 
Manufacturer Narrative
Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
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Brand Name
ASEPTICO 10K TORQUE CONTROL MOTOR
Type of Device
UNIT, OPERATIVE DENTAL
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
MDR Report Key8219674
MDR Text Key132345413
Report Number2320721-2018-00210
Device Sequence Number1
Product Code EIA
Combination Product (y/n)N
PMA/PMN Number
K882526
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAM8B
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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