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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 Retraction Problem (1536)
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. Multiple unsuccessful attempts were made to obtain the device for evaluation.
 
Event Description
It was reported that an aseptico dtc endo motor was improperly auto-reversing; no injury resulted.
 
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Brand NameASEPTICO ENDO DTC MOTOR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
TULSA DENTAL PRODUCTS LLC
608 rolling hills drive
johnson city TN 37604
Manufacturer (Section G)
ASEPTICO, INC
8333 216th st se
woodinville WA 98072
Manufacturer Contact
karl nittinger
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494424
MDR Report Key7962381
MDR Text Key123948454
Report Number2320721-2018-00157
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030163
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 10/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAEU-25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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