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	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Female patient sustaining a full thickness burn on her abdomen following treatment with morpheus8 applicator.Investigation is ongoing.
Event or Problem Description
Full thickness burn on abdomen of a female patient treated with morpheus8.
Additional Manufacturer Narrative
(b)(6) 2025: follow-up report is submitted with investigation conclusions: no technical issues were revealed during technical inspection of the device.There was an off label use of the device on the abdomen, and the doctor intended to treat "fibrosis and irregularities post vaser liposuction".This also implies lack of thick adipose layer in the treatment area.The doctor utilized very aggressive treatment parameters, pulsing excessively on the same spot, which was further exacerbated by lack of adipose layer.Additionally, inefficient heat dissipation in the fibrotic tissue also could have contributed to the thermal damage.The clinic has received a retraining.
Event or Problem Description
Full thickness burn on abdomen of a female patient treated with morpheus8.

• 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: 22791795
• Report Number: 3010511300-2025-00884
• Device Sequence Number: 8634250
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Patient Monitoring,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: AG609126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2024
• 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: 34 YR
• Patient Sex: Female
• Patient Race: White