MAUDE Adverse Event Report: INMODE LTD LUMECCA; INTENSE PULSED LIGHT

Model Number	AS601863A
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A full thickness burn (3rd degree) of rectangular shape and dimensions of approximately 2 x 1 cm located in the center of right malar area following lumecca 515 treatment.
Additional Manufacturer Narrative
Based on the tests and history, there was a component failure, that caused this problem.The current board design answering to double fault condition, it is most unlikely that both q8, and q9, will go bad at the same time during operation.In a retrospective review of technical complaints there were not found any similar circumstances.Patient is healing very well.Opened capa (b)(4).

• Brand Name: LUMECCA
• Common Device Name: INTENSE PULSED LIGHT
• 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: 16821921
• Report Number: 3010511300-2023-00126
• Device Sequence Number: 6820747
• Product Code: ONF
• UDI-Device Identifier: 07290016633108
• UDI-Public: 07290016633108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221571
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Modification/Adjustment,Other,Inspection
• Type of Report: Initial
• Report Date (Section B): 04/27/2023

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
• Operator of Device: Health Professional
• Device Model Number: AS601863A
• Device Catalogue Number: AS601863A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White