MAUDE Adverse Event Report: SONENDO SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPYSYSTEM; ULTRASONIC SCALER

Model Number FG-006-00001

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2015

Event Type  malfunction  

Event Description

After completion of root canal therapy with the sonendo omniclean gentlewave sys, 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

The endodontist discovered that the fluid bottle connector was not fully engaged which interrupted fluid delivery into the system.The endodontist engaged the connector and proceeded to successfully complete two treatments.The field svc engineer ran multiple cycles at the endodontist office to ensure the appropriate volume of fluid was being delivered to the sys.A sys test was conducted and resulted in the sys performing within specification.

• Brand Name: SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPYSYSTEM
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO; laguna hills CA
• Manufacturer Contact: dan miller ; 26061 merit circle; suite 102; laguna hills, CA 92653 ; 9497663636
• MDR Report Key: 4658901
• MDR Text Key: 5732255
• Report Number: 3010817521-2015-00006
• 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: 03/20/2015

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: W2014072502
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/06/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 04/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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: 61 YR