MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG609126A
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	03/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Inflamed rectangular skin reactions reproducing the needle matrix of the tip scattered throughout the entire abdominal area in the hypogastric, umbilical and epigastric regions.This reaction persists 2 months after the treatment performed with morpheus 8.Erythematous-papular lesions are observed corresponding to the needle insertions still in inflammatory phase.Giving a first look at the setting used during the treatment it seems excessive and not compliant with the protocol.This level of intensity characterizes a first and immediate skin reaction.Although the nature of the lesions is to be considered superficial and reversible, such long-term permanence of this stage is not expected and therefore it is decided to report the event to the competent authorities.
Additional Manufacturer Narrative
Apparently there was an excessive setting especially in terms of number of passes, however the case was reported about two months after the treatment and during all this period the clinic has continued to use the device regularly on a daily basis without ever having had a problem.In this case we ask the clinic to monitor the patient to verify effective healing, we also suggest a retrain session to underline the salient points regarding the safety and efficacy of the treatment with our technology.
Additional Manufacturer Narrative
The device was inspected and no relevant findings were detected.The device was not delivering rf in full due to dirt on pogo connector.However, missing rf waveform could not cause any incident and accordingly it was concluded that the incident is not related to the device.The root cause was attributed to a user error: the provider utilized extremely excessive treatment parameters both in terms of energy levels and number of passes.The intense reaction was most probably accentuated by individual hypersensitivity.Despite several attempts to follow up on patient's healing status, no such information could be obtained as the clinic lost contact with the patient.The clinic was retrained on the correct protocol.
Event or Problem Description
Inflamed rectangular skin reactions reproducing the needle matrix of the tip scattered throughout the entire abdominal area in the hypogastric, umbilical and epigastric regions.This reaction persists 2 months after the treatment performed with morpheus 8.Erythematous-papular lesions are observed corresponding to the needle insertions still in inflammatory phase.Giving a first look at the setting used during the treatment it seems excessive and not compliant with the protocol.This level of intensity characterizes a first and immediate skin reaction.Although the nature of the lesions is to be considered superficial and reversible, such long-term permanence of this stage is not expected and therefore it is decided to report the event to the competent authorities.

• 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: 17149820
• Report Number: 3010511300-2023-00261
• Device Sequence Number: 5781880
• Product Code: GEI
• UDI-Device Identifier: 07290016633672
• UDI-Public: 07290016633672
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K192695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection,Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2023

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
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White