MAUDE Adverse Event Report: ALMA LASERS LTD. HYBRID SYSTEM 70W 120V 50/60 HZ; POWERED LASER SURGICAL INSTRUMENT

Model Number	1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Disorders (4543)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported that a patient experienced post inflammatory hyperpigmentation in the treatment area following the use of the hybrid system.We have been unable to confirm the patient's post inflammatory hyperpigmentation has resolved; therefore we are reporting this in good faith.

• Brand Name: HYBRID SYSTEM 70W 120V 50/60 HZ
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD.; 18 haharash street; north industrial park, caesarea 30798 95; IS 3079895
• MDR Report Key: 22074284
• Report Number: 3004450661-2025-00012
• Device Sequence Number: 9363448
• Product Code: GEX
• UDI-Device Identifier: 17290110122109
• UDI-Public: 17290110122109
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2025
• Report Date (Section F): 05/22/2025

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: AACO15061980BDAZ0003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/22/2025
• Device Age: 3 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2025
• 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 Age: 31 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/22/2025