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	02/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinic reported third degree burns on upper arms of a patient treated with morpheus8.Investigation is ongoing.
Event or Problem Description
Full thickness burns on upper arms post morpheus8 treatment.
Additional Manufacturer Narrative
Clinic reported third degree burns on upper arms of a patient treated with morpheus8.Investigation is ongoing.20-aug-2024: follow up report is submitted with investigation results.No technical issues were found upon inspection of the device.The root cause is attributed to user error: the operator utilized extremely aggressive treatment parameters (multiple pulsing at various depths on the same spot with excessive energy levels), not congruent with the ifu, causing severe tissue damage.Customer was retrained.
Event or Problem Description
Full thickness burns on upper arms post morpheus8 treatment.

• 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: 19565754
• Report Number: 3010511300-2024-00546
• Device Sequence Number: 12338820
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Patient Monitoring,Notification,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: AG609126A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2020
• 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