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

Model Number	07290110123369
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	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical evaluation determined that the reported injury is transient in nature and is expected to resolve with standard post-operative care.The reported skin reaction is consistent with known and anticipated adverse reactions associated with energy-based treatments, as described in the device labeling.Based on the information currently available, a definitive root cause has not been established.The manufacturer has requested return of the device for evaluation; however, the device has not yet been returned.The investigation remains ongoing.Should the device be returned and additional information become available, a supplemental (follow-up) report will be submitted upon completion of the device evaluation.This report is submitted in good faith based on the information available at the time of reporting.
Event or Problem Description
The importer reported that a user facility reported that a patient sustained a superficial second degree burn at the treatment site following use of the alma harmony system.
Event or Problem Description
The importer reported that a user facility reported that a patient sustained a superficial second degree burn at the treatment site following use of the alma harmony system.
Additional Manufacturer Narrative
This follow-up report provides the results of the completed clinical and technical investigation.Clinical evaluation determined that the reported injury was transient in nature and expected to resolve with standard postoperative care.The reported skin reaction is consistent with known and anticipated adverse reactions associated with energy-based treatments, as described in the device labeling.The initial report was submitted in an abundance of caution based on the information available at that time.As part of the technical investigation, the clearskin applicator was returned to the manufacturer for evaluation and functional testing.During inspection, a fractured internal component was identified within the applicator, with no energy output.While this observation indicates that the applicator was not in its original condition at the time of analysis, the timing of the fracture and its relationship, if any, to the reported event could not be determined.Based on the available information, a definitive root cause has not been established.The reported event could not be reproduced, and a direct causal relationship between the returned-unit findings and the reported patient outcome could not be confirmed.Potential contributing factors that cannot be excluded include user- or procedure-related factors, such as treatment technique, pulse overlap, applicator handling during pulse delivery, or connection integrity between the applicator and the system.In addition, the fractured internal component identified during the returned-product evaluation may have affected applicator performance; however, there is insufficient evidence to determine whether this condition existed at the time of treatment or contributed to the reported outcome.No new or unanticipated hazards were identified through the investigation.The reported patient outcome remains non-serious and transient, and no additional patient impact has been reported.Based on the available information, the investigation does not support the identification of a new safety signal or trend.

• 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: 24699879
• Report Number: 3004167969-2026-00006
• Device Sequence Number: 21472095
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/18/2026

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 Model Number: 07290110123369
• Device Catalogue Number: AAHG25102201BR0002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Female