MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL MIDWEST E MICRO ELECTRIC CONTROL UNIT; CONTROLLER, FOOT, HANDPIECE AND CORD

Catalog Number 875040

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.This report is for the second patient.Dentsply (b)(4) was unable to demonstrate the returned unit exceeded any current flow limits.Although varying voltages were measured across the motor and sheath, these voltages represent an extremely minute amount of electricity due to the very low current flow associated with them.All current flows were within specifications as per (b)(4) for a medical type ii bf applied part.It is possible that an electro-static discharge from the doctor might have caused an increase of current.It is also possible that electrical current may have flowed through the water pipes at the doctor's office due to a faulty grounding of the pipes.

Event Description

In this event a doctor reported that a midwest e micro electric control unit sent an electrical current through a handpiece to a patient; no injury resulted and no intervention was required.

• Brand Name: MIDWEST E MICRO ELECTRIC CONTROL UNIT
• Type of Device: CONTROLLER, FOOT, HANDPIECE AND CORD
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 901 west oakton st.; des plaines IL 60018
• Manufacturer (Section G): SYCOTEC GMBH & CO KG; wangener strasse 78; leutkirch baden-wurttemberg, 88299 ; GM 88299
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6312094
• MDR Text Key: 66821599
• Report Number: 1419322-2017-00013
• Device Sequence Number: 1
• Product Code: EBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090937
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 875040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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