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

Catalog Number	AASP12091701BA0001
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
Importer reported that user facility reported that a patient sustained a burn at the treatment site following use of the opus system.
Additional Manufacturer Narrative
A single localized burn was reported following treatment with the opus microplasma focus tip.The event is considered transient and is expected to improve with standard post-treatment care.The device was requested for evaluation; however, despite multiple due diligence attempts to coordinate device retrieval, the customer has not responded.Based on the available information, the most probable root cause is related to treatment technique (user error).Based on the information available at the time of assessment, the event does not meet the criteria for mandatory reporting under 21 cfr part 803.However due to possibility of very small residual scar that may remain, it is reported to fda in a good faith.

• 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
• Manufacturer (Section G): ALMA LASERS LTD; 18 haharash street; north industrial park; caesarea, 30798 95; IS 3079895
• Manufacturer Contact: odelia zerbiv ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 25197161
• Report Number: 3004167969-2026-00009
• Device Sequence Number: 10088459
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: 17290110121782
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2026

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 Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female