MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY); POWERED LASER SURGICAL INSTRUMENT

Catalog Number	AAHP02110623GAH10001
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
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 harmony xl pro system.
Additional Manufacturer Narrative
Clinical evaluation determined the injury to be transient, with the possibility of post-inflammatory hyperpigmentation (pih) and/or a mild, small scar.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 has not returned the device and it was not available for evaluation.The device production records (dhr) were reviewed and no anomalies or conditions that could have contributed to the reported event were identified.Based on the available information, the probable root cause is user error during a training session.Potential contributing factors may include failure to perform a skin test, excessive fluence or inappropriate pulse duration, pulse stacking or overlap, inadequate cooling or insufficient gel application.Although this event does not meet fda reportability criteria, this report is being submitted in good faith.The importer also submitted report number to fda.

• Brand Name: HARMONY XL PRO SYSTEM 100-120V (BLACK/GREY)
• 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: 24377546
• Report Number: 3004167969-2026-00003
• Device Sequence Number: 4875004
• Product Code: GEX
• UDI-Device Identifier: 17290110120907
• UDI-Public: 17290110120907
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K072564
• 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): 02/18/2026

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: AAHP02110623GAH10001
• 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: 02/18/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female