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	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The importer reported that user facility reported that a patient sustained burns at the treatment sites following use of the opus system.
Additional Manufacturer Narrative
A patient experienced burn following treatment with the opus colibri applicator.Clinical assessment determined the injury was consistent with localized excessive thermal exposure in a sensitive area, potentially associated with treatment technique, including excessive applicator pressure and insufficient spacing between treatment spots.Follow-up information indicates the patient is healing with progressive improvement; however, post-inflammatory hyperpigmentation and small residual scarring cannot be completely excluded at this stage.Technical evaluation confirmed the device met all manufacturer specifications, and no malfunction or performance deficiency was identified.Based on the available information, the event is considered likely related to treatment-related factors rather than device malfunction.The manufacturer is submitting this mdr in good faith and out of an abundance of caution due to the potential for scarring.

• 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: 50066663
• Report Number: 3004167969-2026-00012
• Device Sequence Number: 21384172
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: 17290110121782
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• 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: 48 YR
• Patient Sex: Female