MAUDE Adverse Event Report: INMODE LTD. MORPHEUS8; GEI

Model Number	AG607401A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Necrosis (1971); Localized Skin Lesion (4542)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Necrotic lesions at injection sites of anesthetic solution following morpheus8 treatment.
Additional Manufacturer Narrative
Technical inspection did not reveal any issues related to the incident.Investigation attributed the root-cause to user errors and additional human factors: morpheus8 treatment was performed on bleeding/bruised injection sites, when the operator should have abstained from performing the treatment once seeing such reaction to the injections.The injection of the anesthetic solution apparently was done incorrectly (too much volume, sites too close to one another, possible incorrect preparation of the solution, e.G.Incorrect concentration of epinephrine and hence increased bleeding).Additional intrinsic factors such as patient's coagulation problems could have contributed to the increased bleeding.The operator used extremely aggressive treatment parameters for morpheus8, not congruent with the ifu, which further contributed to the formation of the lesions.It seems there was some additional mechanical damage to the area post treatment (e.G.By friction with clothes) and secondary infection brought by lack of aseptic conditions post 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: 19758676
• Report Number: 3010511300-2024-00567
• Device Sequence Number: 6579261
• Product Code: GEI
• UDI-Device Identifier: 07290016633412
• UDI-Public: 07290016633412
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Inspection,Patient Monitoring,Notification,Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2022
• 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: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: White