MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ BASIC STARTER KIT (INCLUDES CONTRA ANGLE); CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number A105400000000

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the patient outcome.Received - 1x x-smart iq handpiece h105900000000 sn: (b)(4).X-smart iq handpiece; various electronic problem; start / stop button red led on, but still be operative.Oxide on pressure sensor caused red led.

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.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 a x-smart iq contra angle locked and stopped working during the procedure of root canal treatment.The event outcome is unknown as of this mdr evaluation.

• Brand Name: X-SMART IQ BASIC STARTER KIT (INCLUDES CONTRA ANGLE)
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: karl nittinger ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494424
• MDR Report Key: 9136649
• MDR Text Key: 168529031
• Report Number: 8031010-2019-00153
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: PK
• PMA/PMN Number: K161213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A105400000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1