MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Physician reported over the phone about a patient sustaining burns in the nostrils, on the lip and along the cheek, as a result of a flash fire that occured due to using morpheus8 in proximity with alcohol and oxygen.The treated patient was sedated and was receiving oxygen via nasal cannula.Per doctor, they had just cleaned the face with alcohol and the technician was resuming the morpheus8 treatment before the alcohol was dried, while the oxygen was running through the nasal cannula.The doctor acknowledged the user error, as per ifu using inflammable substances such as aclohol or oxygen constitutes a fire hazard and is listed as warning.As the patient is suing the clinic, the physician became non responsive and no additional information is available at this point (including photos or the clinical form).Nevertheless, it was decided to report this case out of abundance of caution.Should additional information be received, a follow up report will be submitted.
Event or Problem Description
Burns due to using morpheus8 in proximity with oxygen and alcohol.

• 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: 20672511
• Report Number: 3010511300-2024-00679
• Device Sequence Number: 18200617
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K210492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2021
• 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 Sex: Female