MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES E3 TORQUE CONTROL MOTOR; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number E3KIT

Device Problems Overheating of Device (1437); Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2014

Event Type  malfunction  

Event Description

In this event it was reported that an e3 motor failed to auto-reverse and was also overheating; there is no indication that injury resulted.

Manufacturer Narrative

Because failure of the auto-reserve function could possibly lead to file separation, which could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the issue would be likely to cause/contribute to a serious injury should it recur.A such, this event meets 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.

• Brand Name: E3 TORQUE CONTROL MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; johnson city TN
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st., ste 60; susquehanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4117946
• MDR Text Key: 4702252
• Report Number: 9611053-2014-00003
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103653
• 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
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E3KIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1