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U.S. Department of Health and Human Services

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

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DENTSPLY TULSA DENTAL SPECIALTIES PROMARK ENDODONTIC MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number PMKEM1
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
Evaluation found an issue with the front bearing and the foot pedal connector. The motor was repaired and the software was upgraded to the current version.
 
Manufacturer Narrative
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 a promark endo motor was not working properly, possibly causing files to break. The event outcome is unknown as of this mdr evaluation.
 
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Brand NamePROMARK ENDODONTIC MOTOR
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY TULSA DENTAL SPECIALTIES
608 rolling hills drive
johnson city TN 37604
Manufacturer (Section G)
ASEPTICO, INC
8333 216th st se
woodinville WA 98072
Manufacturer Contact
helen lewis
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494229
MDR Report Key6852302
MDR Text Key253265620
Report Number2320721-2017-00059
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,Followup
Report Date 10/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2017
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
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated by Manufacturer? Yes
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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