MAUDE Adverse Event Report: INMODE LTD INMODE LTD; EVOKE CHEEK

Model Number	AG608275A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness (3rd stage) burn on right cheek.
Additional Manufacturer Narrative
The system was tested, and no anomalies were found.Service inspection showed that the system works according to specifications.Summary of related investigations the event was result of a triple fault condition, characterized by extremely low probability: 1.Applicator was placed unproperly in a way that part or the whole applicator was in the air and mislead temperature sensors.2.Since technical inspection did not reveal any failure in patient call button, the only plausible explanation is the patient not pressing the button all the way.3.Treatment attendant was not in the room despite clear instruction in the ifu not to leave the patient unattended, and could not help the patient by removing the mask or pressing device off button to disable the device.After reviewing of safety record for about 500 devices installed around the world the coincidence of these circumstances looks extremely low.

• Brand Name: INMODE LTD
• Common Device Name: EVOKE CHEEK
• Manufacturer (Section D): INMODE LTD; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 16384841
• Report Number: 3010511300-2023-00045
• Device Sequence Number: 17414949
• Product Code: PBX
• UDI-Device Identifier: 07290016633542
• UDI-Public: 07290016633542
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191855
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Inspection
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

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
• Operator of Device: Health Professional
• Device Model Number: AG608275A
• Device Catalogue Number: AG608275A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White