MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC X-SMART IQ MOTOR HANDPIECE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number H105900000000

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received where this malfunction of a similar device 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.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 the reverse auto stop does not function on a x-smart iq.Two instruments broke.Outcome of this event is unknown as of this mdr evaluation.

Manufacturer Narrative

The device was evaluated and found to be within specification.Multiple unsuccessful attempts were made to obtain the patient outcome.

• Brand Name: X-SMART IQ MOTOR HANDPIECE
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): TULSA DENTAL PRODUCTS LLC; 608 rolling hills drive; johnson city TN 37604
• MDR Report Key: 8375760
• MDR Text Key: 137555749
• Report Number: 8031010-2019-00010
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: K161213
• 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: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H105900000000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1