MAUDE Adverse Event Report: MAILLEFER INSTRUMENTS HOLDING SARL X-SMART IQ HANDPIECE; CONTROLLER, FOOT, HANDPIECE AND CORD

Model Number XSIQEM1HSP

Device Problem Mechanical Problem (1384)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

In this event it is reported that a x-smart iq handpiece stopped running during use.The outcome of this event is unknown as of this mdr.Further information requested.

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.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Additional information received that there was no injury in this event.Investigation results: received = 1x x-smart iq handpiece h105900000000 sn: (b)(6).X-smart iq handpiece sav other start / stop button intermittent defect.Replaced 1x iq handpiece h105900000000.

• Brand Name: X-SMART IQ HANDPIECE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer (Section G): MAILLEFER INSTRUMENTS HOLDING SARL; ch. du verger 3; ballaigues vaud CH-13 38; SZ CH-1338
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 17225118
• MDR Text Key: 318231439
• Report Number: 8031010-2023-00803
• Device Sequence Number: 1
• Product Code: EBW
• UDI-Device Identifier: D716XSIQEM1HPS1
• UDI-Public: D716XSIQEM1HPS1
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: XSIQEM1HSP
• Device Catalogue Number: H105900000000
• Device Lot Number: 26407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/16/2023
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1