MAUDE Adverse Event Report: ALMA LASERS LTD ALMA HARMONY; POWERED LASER SURGICAL INSTRUMENT

Catalog Number	AAHG25102201BR0002
Medical Device Problem Codes	Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The importer reported that a user facility reported that one of their patients experienced a significant burn at the treatment site following the use of the alma harmony system.The investigation determined the injury to be a second-degree burn; therefore, we are reporting this in good faith.
Event or Problem Description
The importer reported that user facility reported that one of their patients experienced a significant burn at the treatment site following the use of the alma harmony system.
Additional Manufacturer Narrative
This follow-up report provides the results of the completed technical and clinical investigation.The reported event involved burn, classified as a minor injury, following the use of the alma harmony system with the clearskin applicator.The patient received conservative topical treatment only, and no surgical or advanced medical intervention was required.As part of the investigation, the clearskin applicator was returned to the manufacturer and subjected to testing.Inspection identified a faulty internal rod within the applicator.In parallel, communication with the user confirmed a usage deviation from the instructions for use.Based on the investigation findings, the event was determined to be caused by a combination of user-related factors and a faulty component.The condition identified is addressed through existing corrective actions.No new or unanticipated hazards were identified.The injury outcome remains non-serious and transient, and no further patient impact has been reported.
Event or Problem Description
The importer reported that user facility reported that one of their patients experienced a significant burn at the treatment site following the use of the alma harmony system.

• Brand Name: ALMA HARMONY
• 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: 23359979
• Report Number: 3004167969-2025-00021
• Device Sequence Number: 9091088
• Product Code: GEX
• UDI-Device Identifier: 07290110123369
• UDI-Public: 07290110123369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 01/29/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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: 46 YR
• Patient Sex: Female