MAUDE Adverse Event Report: SONENDO INC. SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPY SYSTEM

Model Number FG-006-00001

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  malfunction  

Event Description

After completion of root canal therapy with the sonendo omniclean gentlewave system, it was observed by the endodontist that the expected volume of treatment fluid was not consumed.No pt injury was reported in this event.

Manufacturer Narrative

A field service engineer serviced the device in question at the endodontist's office.The engineer discovered that a component of the fluid bottle (female) connector was broken, which interrupted fluid delivery into the system.The engineer simulated the failure by running three treatment cycles of the system to completion.The cycles verified the user's description of the event.The female connector with "new from stock" parts and subsequently ran multiple cycles to ensure the appropriate volume of fluid was being delivered to the system.After the components were replaced, a system test was conducted and resulted in the system performing within specification.This service activity is consistent with sonendo's preventive maintenance plan for the system fluid bottles.

• Brand Name: SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPY SYSTEM
• Manufacturer (Section D): SONENDO INC.; laguna hills CA
• Manufacturer Contact: dan miller ; 26061 merit circle; suite 102; laguna hills, CA 92653 ; 9497663636
• MDR Report Key: 4600525
• MDR Text Key: 5465841
• Report Number: 3010817521-2015-00001
• Device Sequence Number: 1
• Product Code: ELC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG-006-00001
• Device Catalogue Number: FG-006-00001
• Device Lot Number: W2014111303
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2015
• Initial Date FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 73