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

Catalog Number EJKIT

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

In this event a doctor reported that an e3 motor was not reciprocating and gave a calibration error, possibly causing several files to separate.

Manufacturer Narrative

Because eval of the unit involved is not complete as of this report and 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, it must be presumed that the device malfunctioned and that the 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 file separation events will be reported via asr, as appropriate.

• 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; susquenhanna commerce center w.; york, PA 17401 ; 7178457511
• MDR Report Key: 4265057
• MDR Text Key: 20973674
• Report Number: 9611053-2014-00004
• 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: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/22/2014

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: EJKIT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/22/2014
• 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