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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED

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DENTSPLY MAILLEFER X-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
While there is no indication that serious injury resulted in this event, 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
In this event it was reported that a x-smart equipment suddenly stopped during root canal treatment. There was no patient's injury.
 
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Brand NameX-SMART ENDO MOTOR WITH CONTRA ANGLE HANDPIECE
Type of DeviceHANDPIECE, DIRECT DRIVE, AC-POWERED
Manufacturer (Section D)
DENTSPLY MAILLEFER
chemin du verger 3
ballaigues, 1338
SZ 1338
Manufacturer (Section G)
NAKANISHI INC.
700 shimohinata
kanuma-shi, 322-8 666
JA 322-8666
Manufacturer Contact
hannah seevaratnam
221 w. philadelphia st.
suite 60w
york, PA 17401
7178494593
MDR Report Key12368911
MDR Text Key268208136
Report Number8031010-2021-00194
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
PMA/PMN Number
K990682
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA100400000000
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
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 Unkown

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