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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC PROMARK ENDODONTIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED

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TULSA DENTAL PRODUCTS LLC PROMARK ENDODONTIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number PMKEM1
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
In this event it was reported a promark endo motor was not beeping warning for too much torque; no injury resulted.
 
Manufacturer Narrative
There has not 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.
 
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Brand NamePROMARK ENDODONTIC 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
hannah seevaratnam
221 w. philadelphia st.
york, PA 17401
7178494593
MDR Report Key12727859
MDR Text Key281009363
Report Number2320721-2021-00087
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111078
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 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMKEM1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? No
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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