MAUDE Adverse Event Report: DENTSPLY MAILLEFER X-SMART EASY; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number A102200000000

Device Problems Power Conditioning Problem (1474); 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.Please note that while this product is not sold in the us, it is considered similar to products that are marketed in the us by dentsply sirona.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event, it was reported that x-smart easy suddenly stops in the channel.There was no injury to the patient.

Manufacturer Narrative

X-smart head assembly.Sav various mechanical problem.Corroded.X-smart head cap.Sav bad maintenance (user).The file is hard to remove, this failure is probably caused by rust or other foreign matter in the head cap.X-smart easy battery.Sav defective battery.Battery is out of work.X-smart cartridge.Sav various mechanical problem.I note that the cartrigde is blocked.X-smart neck.Sav various mechanical problem.Ball bearing of the neck is defective.It is not possible to be determined the root cause with certainty.The root cause is either a mechanical problem or a bad maintenance of user.

• Brand Name: X-SMART EASY
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY MAILLEFER; chemin du verger 3; ballaigues, 1338 ; SZ 1338
• MDR Report Key: 8219682
• MDR Text Key: 132801272
• Report Number: 8031010-2018-00156
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A102200000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1