MAUDE Adverse Event Report: INMODE LTD MORPHEUS8; GEI

Model Number AG607401A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Peripheral Nervous Injury (4414)

Event Type  Injury  

Manufacturer Narrative

It is likely that the temporary injury to the marginal mandibular nerve was caused during the maneuver of the nerve block administered in the mandibular area near the course of the affected nerve.The actual ability of frf to damage the mandibular nerve are negligible considering the mode of penetration of the needles, the depth of action and the fact that we have never had a similar case, having a history of hundreds of thousands of treatments with m8 investigation conclusions: the administration of a nerve block at the mandibular level would in all likelihood have generated a temporary injury to the marginal mandibular nerve as a neurapraxia.

Event Description

Mandibular nerve palsy on right side post morpheus8 treatment most probably due to the administration of nerve block.

Event Description

Mandibular nerve palsy on right side post morpheus8 treatment most probably due to the administration of nerve block.

Manufacturer Narrative

1.H6: health effect - impact code - changed to 4619.2.H11: attached: upon arrival test final test in service report (retrain).

• Brand Name: MORPHEUS8
• Type of Device: 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: eran krieger ; tavor building (pob 533); shaar yokneam; yokneam northern, north 20692-06 ; IS 2069206
• MDR Report Key: 16387088
• MDR Text Key: 309670888
• Report Number: 3010511300-2023-00074
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 07/05/2023

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
• Device Operator: Health Professional
• Device Model Number: AG607401A
• Device Catalogue Number: AG607401A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White