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

Catalog Number	AAHG25102201BR0002
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation classified the reported injury as a localized burn, assessed as mild and transient, with expected full resolution under standard post-treatment care.The device operator manual (om) identifies burn as a potential adverse reaction.The device was requested for return to support further investigation.Multiple due diligence attempts were made retrieve the device; however, the customer has not returned the device and it was not available for evaluation.Therefore, device performance could not be confirmed or ruled out.Based on the limited information available, water leakage from the applicator was identified as a probable contributing factor.The leakage may have resulted from improper applicator connection or a potential system malfunction; however, the root cause cannot be confirmed without device inspection.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 currently available information, there is no evidence of a device malfunction that, if it were to recur, would be likely to cause or contribute to a serious injury as defined in 21 cfr 803.3.Although this event does not meet fda reportability criteria, this report is being submitted in good faith.The importer also submitted report number 3004450661-2026-00002 to fda.
Event or Problem Description
The importer reported that user facility reported that a patient sustained a burn at the treatment site following use of the alma harmony system.The facility further reported that the clearskin handpiece used with the alma harmony system during the treatment began leaking water after the burn occurred.

• 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: 24316818
• Report Number: 3004167969-2026-00002
• Device Sequence Number: 4875280
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2026

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: 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: 01/12/2026
• Initial Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (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 Sex: Unknown