MAUDE Adverse Event Report: INMODE LTD. INMODE RF; GEI

Model Number	AG606969A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Transient paresis after facette and morpheus 8 treatment.
Additional Manufacturer Narrative
Patient presented with transient paresis of the right lower lip following procedure of facette and morpheus8.The handpiece was discarded and hence not inspected.However, system inspection did not reveal any technical issues.The reported paresis was concluded to be a result of working with the facetite handpiece in the "no fly" zone (over the marginal mandibular branch of the facial nerve) thus causing neurapraxia.Patient has fully recovered and re-training has been scheduled for the doctor.

• Brand Name: INMODE RF
• 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: 19640801
• Report Number: 3010511300-2024-00532
• Device Sequence Number: 7118887
• Product Code: GEI
• UDI-Device Identifier: 07290016633337
• UDI-Public: 07290016633337
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K233642
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection,Notification,Patient Monitoring,Other
• Type of Report: Initial
• 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: Health Professional
• Device Model Number: AG606969A
• Device Catalogue Number: AG606969A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2017
• 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: 59 YR
• Patient Sex: Female
• Patient Race: White