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

Catalog Number E3KIT

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problems Shock (2072); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

There has been a previous report received with a similar device where stalling or a sudden stop has caused file separation.Separation of a file could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function.Furthermore, electrical shock could also necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, if it recurred.As such, this event meets the 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.

Event Description

It was reported that an e3 unit foot pedal stopped working during use.The assistant then used the e3 button to start and stop the file.However, that stopped working as well so the assistant had to manually hold the button until the doctor wanted the file to stop.While holding the button, the unit was "lightly shocking" the assistant.

Manufacturer Narrative

Evaluation found that the foot pedal has a interrupted wire.

• 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 ; 7178457551
• MDR Report Key: 6490980
• MDR Text Key: 72954990
• Report Number: 2320721-2017-00033
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2017
• 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