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

Catalog Number E3KIT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Since failure of speed or problems with reciprocating 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.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event, it has been reported that the speed of an e3 motor is too slow and it does not reciprocate as smoothly; no injury resulted.

• Brand Name: E3 MOTOR
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY TULSA DENTAL SPECIALTIES; 608 rolling hills drive; johnson city TN 37604
• Manufacturer (Section G): ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L.; via san donato 1; pistoia, 51100 ; IT 51100
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 5565172
• MDR Text Key: 42947040
• Report Number: 9611053-2016-00011
• 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: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• 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: 03/11/2016
• 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: Unknown
• Patient Sequence Number: 1