MAUDE Adverse Event Report: ALMA LASERS LTD. SOPRANO TITANIUM SYSTEM 230V; DERMATOLOGICAL DIODE LASER SYSTEM

Model Number	1
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Burn(s) (1757); Hyperpigmentation (4837)
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced what appears to be a third-degree burn at the treatment site following the use of the soprano titanium system.

• Brand Name: SOPRANO TITANIUM SYSTEM 230V
• Common Device Name: DERMATOLOGICAL DIODE LASER SYSTEM
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 21712546
• Report Number: 3004450661-2025-00007
• Device Sequence Number: 10071596
• Product Code: GEX
• UDI-Device Identifier: 17290110121829
• UDI-Public: 17290110121829
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/27/2025
• Report Date (Section F): 03/27/2025

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: AASP05091845BSR0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2025
• Device Age: 13 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/27/2025