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	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The event involved a burn during a treatment with hybrid system, which may result in a small scar in the brow area.Burns, blisters, and scarring are anticipated adverse events documented in the hybrid operator's manual.The device was not returned for evaluation; however, a recent installation and qc report confirmed the system functioned properly and met manufacturer specifications.No evidence of device malfunction was identified based on available information.The investigation indicates the event was associated with treatment parameters and technique, consistent with a user-related cause.This report is submitted in good faith in accordance with 21 cfr part 803 due to the possibility of a permanent scar.The event was also reported by the importer under report number 3004450661-2025-00025.
Event or Problem Description
The importer reported that following use of the hybrid system at a user facility, a patient experienced a burn at the treatment site.

• 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
• 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: 23768671
• Report Number: 3004167969-2025-00025
• Device Sequence Number: 9750542
• Product Code: GEX
• UDI-Device Identifier: 17290110122109
• UDI-Public: 17290110122109
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K203441
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/10/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female