MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. ULTRASONIC SCALING UNIT; MINIMASTER LED

Model Number FT-201

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

The dentist complained that he and his patients were hit by electricity during treatment.He even claimed that his hand was swollen as the current passed through his hand.

Manufacturer Narrative

The device has been tested by the after sale service and the security test showed that the device is compliant to iec-60601.Thus, the device is currently being assessed by our product quality compliance department.We also requested a medical report to the compliant.The risk of electrical discharges has been identified within our risk analysis and for the time being we could not establish any link between the electrical discharges and the symptoms reported.

• Brand Name: ULTRASONIC SCALING UNIT
• Type of Device: MINIMASTER LED
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: virginine siloret ; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260 ; 1229944700
• MDR Report Key: 3948865
• MDR Text Key: 4601530
• Report Number: 3004096429-2014-00003
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FT-201
• Device Catalogue Number: FT-201#A/004
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2009
• 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
• Patient Outcome(s): Other