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

Catalog Number A105400000000

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

In this event it is reported that x-smart iq basic starter kit was not having a fluid rotation and while in use with propex iq apex locator the device was giving incorrect measurements.Outcome of this event is unknown as of this mdr.

Manufacturer Narrative

While there is no indication that serious injury resulted in this event, there has been a previous report received 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.Investigation summary: received = 1x x-smart iq contra-angle a105100000000 sn: (b)(4).1x x-smart iq handpiece h105900000000 sn: (b)(4).1x x-smart iq universal charger a105300000000 1x propex iq x-smart iq measurement cable b00ppiq1achpa 1x propex iq propex iq charger b00ppiq1acchg 1x propex iq propex iq file clip x2 b00ppiq2acfcl 1x propex iq propex iq unit bspppiq000002 sn: (b)(4).X-smart iq contra-angle.Sav various mechanical problem.Noisy, not fluid rotation.X-smart iq handpiece.Sav other.Connector broken.Propex iq propex iq unit.Sav defective battery.Battery discharging too fast.Propex iq x-smart iq measurement cable.Sav various cable problem.Bad contact.All complaints are monitored through the monthly product surveillance committee and a corrective action could be determined by the committee.

Manufacturer Narrative

Additional information has been received that there was no injury that occurred for this event.This follow up report is for this additional information.

• Brand Name: X-SMART IQ BASIC STARTER KIT
• 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: 15500899
• MDR Text Key: 306325646
• Report Number: 8031010-2022-00645
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K161213
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: A105400000000
• Device Lot Number: 1046, 25572,00662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/20/2022
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1