MAUDE Adverse Event Report: ALMA LASERS LTD OPUS

Catalog Number	AASP12091701BA0001
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Device Handling Problem (3265)
Health Effect - Clinical Codes	Burn(s) (1757); Scar Tissue (2060)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Burn and possible scar from focus-in tip, opus plasma.
Event or Problem Description
It was reported about a burn and possible scar following opus plasma treatment.
Additional Manufacturer Narrative
Burn and possible scar from focus-in tip, opus plasma.Udi related data quality updates only: this supplemental report represents a correction to a previously submitted mdr the correction is performed following fda request, the udi number was added.
Event or Problem Description
It was reported about a burn and possible scar following opus plasma treatment.

• Brand Name: OPUS
• Common Device Name: OPUS
• 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: avi hirshnzon ; 18 haharash street; north industrial park; caesarea, 30798-95 ; IS 3079895
• MDR Report Key: 18390450
• Report Number: 3004167969-2023-00017
• Device Sequence Number: 19507827
• Product Code: GEI
• UDI-Device Identifier: 17290110121782
• UDI-Public: (01)17290110121782(11)22-05-19
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201520
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 12/25/2023
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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 Sex: Female