MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Scar Tissue (2060); Hypopigmentation (4838)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation concluded that the root cause can be attributed to a user error: the treatment was performed with extremely high energy levels, not congruent with the ifu, and incorrect technique, leading to thermal and mechanical damage of the treated area, which later resulted in scars.The device was not inspected following confirmation from the clinic that this was an isolated incident and the clinic continues to use the device without any issues since this incident.The clinic confirmed that there were no more adverse events since the clinic started to use the recommended parameters.
Event or Problem Description
Scarring on forehead.

• Brand Name: MORPHEUS8
• Common Device Name: GEI
• Manufacturer (Section D): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer (Section G): INMODE LTD.; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692 06; IS 2069206
• Manufacturer Contact: lina korsensky ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 19572934
• Report Number: 3010511300-2024-00548
• Device Sequence Number: 11776508
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200947
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification,Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Female
• Patient Race: White