MAUDE Adverse Event Report: ALMA LASERS LTD. OPUS SYSTEM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	1
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient sustained a burn at the treatment site following use of the opus system.Alma lasers inc.Conducted an investigation and determined that the event was most likely attributable to user technique.However, as the injury is expected to result in scarring, this event is being reported in good faith.The device was requested for evaluation; however, despite multiple due diligence attempts by alma lasers inc.To coordinate device retrieval, the customer has not responded.

• Brand Name: OPUS SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95,; IS 3079895,
• MDR Report Key: 25151394
• Report Number: 3004450661-2026-00009
• Device Sequence Number: 10745693
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: 17290110121782
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/12/2026
• Report Date (Section F): 05/12/2026

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: 04/15/2026
• Device Age: 23 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/12/2026