MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM WITH ACCUTITE HANDPIECE; GEI

Model Number	AG604881A
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient presented with neurapraxia of the left side of the mouth almost 2 months post accutite treatment.Investigation is ongoing.
Event or Problem Description
Neurapraxia of the mouth after accutite procedure.
Additional Manufacturer Narrative
The patient presented with neurapraxia of the left side of the mouth almost 2 months post accutite treatment.Investigation is ongoing.30-oct-2024: follow up report is submitted to perform corrections and to submit investigation results.D1 was corrected.E1 (title) was updated to ms.E3 was corrected to nurse.Investigation results: no technical issues were found in the system during service inspection.The handpiece was discarded and hence could not be inspected.Investigation attributed the root cause to user errors: the reported neuropraxia was caused by working in the "no fly" zone, close to the branches of the facial nerve, using excessive cut off temperature not congruent with ifu.Additionally, it appears the nurse did not inject enough tumescent which contributed to the nerve damage.None the less, the condition has almost fully resolved.The customer was retrained.
Event or Problem Description
Neurapraxia of the mouth after accutite procedure.

• Brand Name: INMODE RF SYSTEM WITH ACCUTITE HANDPIECE
• 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: 19466051
• Report Number: 3010511300-2024-00541
• Device Sequence Number: 17035660
• Product Code: GEI
• UDI-Device Identifier: 07290016633016
• UDI-Public: 07290016633016
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Remedial Action: Inspection,Patient Monitoring,Notification,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: AG604881A
• Device Catalogue Number: AG604881A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2024
• Supplement Date Received by Manufacturer: 05/11/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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 Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White