MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness burns on anterior neck and mandible.
Additional Manufacturer Narrative
Full thickness burns on a female patient treated with morpheus8.Investigation is ongoing.
Additional Manufacturer Narrative
Full thickness burns on a female patient treated with morpheus8.Investigation is ongoing.30-oct-2024: follow up report is submitted with investigation results.The device was inspected and no issues related to the reported burns were identified.The investigation attributed the root cause to user errors: the provider utilized extremely aggressive treatment settings not congruent with the ifu: extremely high energy levels at various depths, multiple stackings/pulses on the same spot, and using a tip not suitable for the treatment area.Per latest photos provided to inmode, the patient has trivial barely visible scars.The clinic has been retrained.
Event or Problem Description
Full thickness burns on anterior neck and mandible.

• 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: 20246481
• Report Number: 3010511300-2024-00632
• Device Sequence Number: 20655879
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Remedial Action: Notification,Inspection,Other,Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: Other
• Device Model Number: AG609126A
• Device Catalogue Number: AG609126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2024
• Supplement Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2022
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White