MAUDE Adverse Event Report: ALMA LASERS LTD OPUS SYSTEM

Catalog Number AASP12091701BA0001

Device Problems Use of Incorrect Control/Treatment Settings (1126); Device Handling Problem (3265)

Patient Problems Burn(s) (1757); Scar Tissue (2060)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

Burn and possible scar from focus-in tip, opus plasma.

Event Description

It was reported about a burn and possible scar following opus plasma treatment.

• Brand Name: OPUS SYSTEM
• Type of Device: 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
• MDR Text Key: 331284061
• Report Number: 3004167969-2023-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Report Date: 12/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: AASP12091701BA0001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female