MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Catalog Number	AG607401A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	06/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted in compliance with fda regulations 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.Inmode has provided all relevant information known to the company as of the submission date of this report and will file a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that three days after the sterile tip was used on a patient, the same sterile tip was re-used on a different patient, resulting in a potential exposure to pathogens.Upon discovery of the device reuse, the patient was notified and encouraged to seek appropriate medical treatment and testing.At the time of this report, no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
This report is submitted in compliance with fda regulations 21 cfr part 803 and should not be considered to be an admission that any inmode product is defective or caused serious injury.Inmode has provided all relevant information known to the company as of the submission date of this report and will file a supplemental report if additional relevant information becomes known.(b)(6) 2025: a folllow-up report is submitted with additional information.The subject patient has informed inmode that she has been tested for possible pathogens and has tested negative.The patient is undergoing a proactive, preventative regimen of medication, and will undergo further testing in the coming months to confirm the negative results.Inmode has also tested the used tip for pathogens and the results came back negative.
Event or Problem Description
It was reported that three days after the sterile tip was used on a patient, the same sterile tip was re-used on a different patient, resulting in a potential exposure to pathogens.Upon discovery of the device reuse, the patient was notified and encouraged to seek appropriate medical treatment and testing.At the time of this report, no patient complications have been reported as a result of this event.

• 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: 22307613
• Report Number: 3010511300-2025-00865
• Device Sequence Number: 8081787
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Other,Patient Monitoring,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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 Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2024
• 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 Ethnicity: Non Hispanic
• Patient Race: White