MAUDE Adverse Event Report: DENTSPLY TULSA DENTAL SPECIALTIES E3 TORQUE CONTROL MOTOR

Catalog Number E3KIT

Device Problems Break (1069); Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

In this event it was reported that several files broke while using an e3 motor and the doctor does not think that the settings on the unit are correct.No injury resulted.

Manufacturer Narrative

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 eval, though has not been returned as of this report.Eval results will be submitted as they become available.

Manufacturer Narrative

The device was evaluated and found to be within specification.

• Brand Name: E3 TORQUE CONTROL MOTOR
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; johnson city TN
• Manufacturer Contact: helen lewis ; 221 n philadelphia ctr w; susquehanna commerce ctr w., ste 60; york, PA 17401 ; 7178457511
• MDR Report Key: 4862588
• MDR Text Key: 15913394
• Report Number: 9611053-2015-00021
• 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,health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2015
• 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: Reuse
• Patient Sequence Number: 1