MAUDE Adverse Event Report: TULSA DENTAL PRODUCTS LLC E3 6:1 CONTRA ANGLE; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number E3CONTRA

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device 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.Past life expectancy (2012).Product will not be returned for evaluation, the customer needs to purchase a new device.

Event Description

In this event it was reported that a e3 contra angle won't hold files.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Additional information received indicating that no injury resulted.

• Brand Name: E3 6:1 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
• MDR Report Key: 8802736
• MDR Text Key: 151601926
• Report Number: 2320721-2019-00130
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• PMA/PMN Number: K103653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

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: E3CONTRA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1