MAUDE Adverse Event Report: ALMA LASERS LTD OPUS

Catalog Number	AASP12091701BA0001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The importer reported that user facility reported that a patient experienced burns at the treatment site following the use of the opus system.
Event or Problem Description
The importer reported that user facility reported that a patient experienced burns at the treatment site following use of the opus system.

• Brand Name: OPUS
• Common Device Name: OPUS
• Manufacturer (Section D): ALMA LASERS LTD; 18 haharash street; north industrial park; 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: 22078005
• Report Number: 3004167969-2025-00010
• Device Sequence Number: 9547878
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)240723
• Combination Product (Y/N): N
• 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): 05/23/2025

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 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: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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 Sex: Female