MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Full thickness burns on gluteal fold and thighs.
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.(b)(6) 2024: fu report is submitted with investigation conclusions.Technical inspection of the device did not reveal any issues that could have led to the reported burn.Investigation attributed the root cause to user error: the treatment settings were extremely aggressive and completely not congruent with the ifu.Multiple passes were done at multiple depths, with energy exceeding the recommended, pulsing was done with high overlap, with multiple pulses on the same spot and extremely high number of total pulses.All this combined with patient not having a thick fat layer.Such excess of energy on the same spot led the observed thermal tissue damage and necrosis.Currently, the patient is healing well and the clinic has been retrained.
Event or Problem Description
Full thickness burns on gluteal fold and thighs.

• 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: 20246410
• Report Number: 3010511300-2024-00631
• Device Sequence Number: 20682052
• 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,Patient Monitoring,Other,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2024

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: 09/29/2024
• 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: 77 YR
• Patient Sex: Female
• Patient Race: Asian