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

Model Number	HP1022B6A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Treatment provider reported of a female patient sustaining neurapraxia of the buccal branch of the facial nerve 5 days post quantum rf procedure, manifested as "difficulty with drinking from a straw, some difficulty with brushing her teeth and some issues with word enunciation.".On the provided photos, an elderly female patient presented an asymmetrical smile, with the left side not contracting upwards.
Additional Manufacturer Narrative
The customer declined service inspection of the device and confirmed the device functions properly with no technical issues.Investigation attributed the root cause to an incorrect usage of the quantum rf handpiece.Although following quantumrf the patient was also treated with morpheus8, the reported neurapraxia is attributed to quantumrf device only, due to morpheus8's fractional superficial mechanism of action, whereas neurapraxia is a known risk of the invasive rfal procedure when working in the "no fly" zone, in proximity to the branches of the facial nerve.Additionally, the operator utilized a rather aggressive treatment settings for quantum rf, exceeding our recommended protocol (second pass on a lean face and too many pulses which resulted in excessive total energy delivered to the area).Altogether, this contributed to the observed neurapraxia.Nevertheless, from our previous experience, such condition is of a transient nature, and indeed, per latest update of 1 week post tx, the patient's condition is improving.A retraining has been scheduled for the clinic and inmode will continue to monitor patient's recovery progress.

• Brand Name: QUANTUM 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: 23815214
• Report Number: 3010511300-2025-00979
• Device Sequence Number: 13108083
• Product Code: GEI
• UDI-Device Identifier: 07290019863069
• UDI-Public: 07290019863069
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K240780
• 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: Nurse
• Remedial Action: Notification,Patient Monitoring,Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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 Model Number: HP1022B6A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Race: White