MAUDE Adverse Event Report: ALMA LASERS LTD ALMA HARMONY CONSOLE WITH GREEN DIODE; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation determined that the injury was transient and is expected to resolve within a few weeks.The reported skin reaction is consistent with known and anticipated adverse reactions associated with energy based treatments.The device was requested for return to support further investigation.Multiple due diligence attempts were made to retrieve the device; however, the customer did not return the device, and therefore it was not available for evaluation.A review of the device history records (dhr) identified no anomalies or conditions that could have contributed to the reported event.Based on the available information, the most probable root cause is user error.Potential contributing factors may include failure to perform a skin test, pulse stacking or overlap, and inadequate post treatment care.Although this event does not meet fda reportability criteria, this report is being submitted in good faith.The importer also submitted report number 3004450661-2026-00004 to the fda.
Event or Problem Description
The importer reported that a user facility reported that a patient sustained a burn at the treatment site following use of the alma harmony system.

• Brand Name: ALMA HARMONY CONSOLE WITH GREEN DIODE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• 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: 24389612
• Report Number: 3004167969-2026-00004
• Device Sequence Number: 16081742
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233024
• 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): 02/19/2026

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: AAHG25102201BR0002
• 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: 01/23/2026
• Initial Report FDA Received Date: 02/19/2026
• 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 Sex: Unknown