MAUDE Adverse Event Report: SONENDO, INC. SONENDO GENTLEWAVE SYSTEM; ULTRASONIC SCALER

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Swelling (2091)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

The handpiece when used with the console is referred to as the gentlewave system.Neither single use device/handpiece nor the console was returned for evaluation.Since the handpiece was not returned, the model and lot number could not be determined.

Event Description

Customer reported that during patient examination, there was a negative response to cold test, percussion and palpation.Radiographic and cbct examination confirmed the presence of a large periradicular lesion around the root of tooth #9 and a calcified pulp chamber floor.Based on the findings, a diagnosis of pulp necrosis with asymptomatic apical periodontitis was made and root canal treatment with gentlewave procedure was planned.The tooth was prepared for gentlewave procedure per gentlewave protocol.Access cavity was prepared, and root canal was instrumented.The doctor mentioned that the root canal was extremely calcified, but he was able to negotiate and instrument the canal with no significant loss of tooth structure or complication.A gentlewave procedure was performed successfully with no issues or complaint.Root canal was obturated and the access cavity was permanently sealed.On friday (b)(6) 2018, dr.(b)(6) was contacted by the patient stating that she was experiencing pain in the area associated with the subject tooth and the symptom wasn't responding to the prescribed analgesic, 600 mg ibuprofen q4-6.The doctor explained to the patient the potential flare up that could happen within 72 hours after root canal procedure.Also, since the patient was nursing, has allergy to penicillin and did not display systemic symptoms, both the doctor and the patient decided to hold off on prescribing or taking antibiotic.However, later that day, the patient contacted the doctor stating that the intensity of pain was still significant, and she started to have a low grade fever.Therefore, 300 mg clindamycin was prescribed and the patient was instructed to take 2 caps immediately followed by 1 every three hours.On sunday (b)(6) 2018, the patient reported that she had swelling on her upper lip and left cheek area that woke her up at 2 am in the morning.With follow up information provided by the customer, the patient was advised to receive an emergency treatment at a hospital since the doctor was unable to see her that same day.The patient received iv clindamycin and prescribed hydrocodone that same afternoon.The patient stated that she was feeling better at night but monday morning, (b)(6) 2018, she informed the doctor via text/picture message that the pain was more intense, and the swelling had increased on her upper lip and left cheek making her unable to open her left eye.Dr.(b)(6) arranged an emergency visit to an oral surgeon for incision and drainage on that same day, a lot of pus was drained as it was reported by the oral surgeon.The patient was contacted the next day, and she explained that she was feeling much better; that the pain subsided completely and there was only a small amount of swelling on her upper lip area.The patient was clinically examined on thursday (b)(6) 2018 by dr.(b)(6), the extra-oral swelling was completely resolved, and she only had small intra-oral swelling on the labial surface associated with the apex of tooth #9.300 mg clindamycin, four times a day was prescribed for the patient.After a follow-up call a week after, the patient stated that all symptoms had resolved, and she was completely back to normal except for some numbness at the site of incision and drainage.The patient will be evaluated for healing within a few months.

• Brand Name: SONENDO GENTLEWAVE SYSTEM
• Type of Device: ULTRASONIC SCALER
• Manufacturer (Section D): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills CA 92653
• Manufacturer (Section G): SONENDO, INC.; 26061 merit circle, suite 102; laguna hills CA 92653
• Manufacturer Contact: eric simon ; 26061 merit circle, suite 102; laguna hills, CA 92653 ; 9497663636
• MDR Report Key: 7498685
• MDR Text Key: 107733817
• Report Number: 3010817521-2018-00002
• Device Sequence Number: 1
• Product Code: ELC
• UDI-Device Identifier: 00858395006226
• UDI-Public: 00858395006226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160905
• 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: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENTLEWAVE CONSOLE AND PROCEDURE INSTRUMENT
• Patient Outcome(s): Hospitalization; Required Intervention