MAUDE Adverse Event Report: INMODE LTD BODYTITE

Model Number AG604881A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

Despite more requests to date we have not obtained the information relevant to the treatment performed by the doctor.However, excluding problems of a technical nature, it can be deduced from the analysis of the photos that an incorrect handling of the cannula was performed with ascent to the surface in the distal tip and excessive energy delivery contrary to what is instructed in the user manual.

Event Description

2 full-thickness burns (3rd degree) of oval shape about 1 cm in diameter each.Anatomical location not clear in the photo, presumably on the right side of the abdomen.One of the lesions appears devoid of dermal tissue while the other has a necrotic black crust.The wounds require prophylactic medical care in order to prevent secondary infection and to boost the healing process.At the moment, scar formations in correspondence with the lesions cannot be excluded.Still awaiting further details from the clinic.

Manufacturer Narrative

Follow up report 07/02/2023.1.User error - the root cause leads to an error in the technique of superficial approach of the cannula to the access port, emitting an excessive energy tantum in the superficial dermal layer.Investigation conclusions: maneuvering error - excess surface energy in the vicinity of the access port.2.Retrain summary isr added.3.Final test added.

Event Description

2 full-thickness burns (3rd degree) of oval shape about 1 cm in diameter each.Anatomical location not clear in the photo, presumably on the right side of the abdomen.One of the lesions appears devoid of dermal tissue while the other has a necrotic black crust.The wounds require prophylactic medical care in order to prevent secondary infection and to boost the healing process.At the moment, scar formations in correspondence with the lesions cannot be excluded.Still awaiting further details from the clinic.

• Brand Name: BODYTITE
• Type of Device: BODYTITE
• 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: 16952371
• MDR Text Key: 315452113
• Report Number: 3010511300-2023-00226
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 07290016633405
• UDI-Public: 07290016633405
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 07/02/2023

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: AG604881A
• Device Catalogue Number: AG604881A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/18/2023
• Supplement Dates Manufacturer Received: 06/06/2023
• Supplement Dates FDA Received: 07/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Sex: Prefer Not To Disclose