MAUDE Adverse Event Report: INMODE LTD. INMODE RF SYSTEM FACE TITE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	HP1010306A
Health Effect - Clinical Codes	Neuropathy (1983); Neuralgia (4413)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient right side of mouth sagging post facetite treatment.Evident neurapraxia in the right lower lip after a facetite treatment on february 11th.Based on our past experience, in such cases, the nature of the injury is almost always transient.Doctor (b)(6) refuses to collaborate with our representatives and would not fill in the ccq, neither accept a technical inspection of the system.Manufacturer case investigation: furthermore, he has announced that he no longer intends to use this technology.The neurapraxia that occurred in this event may have arisen from an involuntary impact of the instrument in the mandibular marginal nerve which in a certain point along the mandibular line protrudes in a superficial position.This results in a temporary neuropathy which usually resolves spontaneously within 2 - 3 months.It is therefore to be considered a mechanical user error related to an incorrect maneuver of the cannula in the area of the path of the marginal mandibular nerve.Fda safety report id # (b)(4).

• Brand Name: INMODE RF SYSTEM FACE TITE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): INMODE LTD.; yokneam iillit 20692 06 I; IS 2069206 IL
• MDR Report Key: 12188979
• Report Number: MW5102617
• Device Sequence Number: 3441451
• Product Code: GEI
• UDI-Device Identifier: 17290016633211
• UDI-Public: 17290016633211
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: HP1010306A
• Device Catalogue Number: HP1010306A
• Device Lot Number: 20-44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1