MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	01/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Neck pain and muscle tension on the left side 1 year post morpheus8 treatment.
Additional Manufacturer Narrative
Initially the incident was reported to inmode in feb 2023 concerning a patient having muscle tension and neck pain 1 month post morpheus8 treatment.Initial investigation concluded that the treatment parameters were too aggressive, whereas technical inspection did not reveal any technical issues.The clinic confirmed that the patient returned almost back to normal.In feb 2024 additional information was received from the clinic stating the patient is still experiencing neck pain and muscle tension on the left side and the condition has not fully resolved.The incident is reported due to longevity of the adverse event.Investigation is ongoing.
Event or Problem Description
Neck pain and muscle tension on the left side 1 year post morpheus8 treatment.
Additional Manufacturer Narrative
Initially the incident was reported to inmode in (b)(6) 2023 concerning a patient having muscle tension and neck pain 1 month post morpheus8 treatment.Initial investigation concluded that the treatment parameters were too aggressive, whereas technical inspection did not reveal any technical issues.The clinic confirmed that the patient returned almost back to normal.In (b)(6) 2024 additional information was received from the clinic stating the patient is still experiencing neck pain and muscle tension on the left side and the condition has not fully resolved.The incident is reported due to longevity of the adverse event.Investigation is ongoing.Follow up narrative: the reported pain/muscle tension seem to stem from a functional neurological problem.However, the tests performed by the patient can diagnose only morphological problems, but not the functional ones.In a healthy patient without a history of thyroidectomy, the incorrect treatment settings used by the operator could not have led to the reported adverse events.Given patient's medical history of partial thyroidectomy on the same side, it is plausible that these functional issues stem from processes not related to the morpheus8 treatment.As no additional information was received from the patient despite inmode's recommendations to diagnose the problem with a neurologist, the exact nature of the adverse event and the root cause could not be established.

• 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: 18824500
• Report Number: 3010511300-2024-00460
• Device Sequence Number: 3047623
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2024

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: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White