MAUDE Adverse Event Report: ALMA LASERS LTD. OPUS SYSTEM; ELECTROSURGICAL CUTTING AND COAGULATION DEVICE

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient developed facial swelling at the treatment site following the use of the opus system.As a result, the user facility alleged that the patient experienced airway compromise which required emergency medical attention and steroids for treatment.

• Brand Name: OPUS SYSTEM
• Common Device Name: ELECTROSURGICAL CUTTING AND COAGULATION DEVICE
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 21913929
• Report Number: 3004450661-2025-00011
• Device Sequence Number: 9081372
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: 17290110121782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2025
• Report Date (Section F): 04/25/2025

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: 1
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/31/2025
• Device Age: 21 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/25/2025