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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART PLUS MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED

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DENTSPLY MAILLEFER X-SMART PLUS MOTOR HANDPIECE, DIRECT DRIVE, AC-POWERED Back to Search Results
Catalog Number A100400000000
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
There has been a previous report received with a similar device where this malfunction resulted in a serious injury. Therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require medical or surgical intervention to preclude such. As such, this event is reportable per 21cfr part 803. Before use, the device won't hold file firmly. The engineer of the hospital found that the head part of device was worn, which led to can't hold file firmly. Equipment has been repaired. After the test performance is qualified, it has been returned to the doctor for normal use. All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.
 
Event Description
In this event it was reported that a x-smart contra angle did not hold files; no injury resulted.
 
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Brand NameX-SMART PLUS MOTOR
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.
york, PA 17401
7178494593
MDR Report Key13506433
MDR Text Key285733524
Report Number8031010-2021-00197
Device Sequence Number1
Product Code EKX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2021
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

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