MAUDE Adverse Event Report: ELLEX MEDICAL PTY LTD INTEGRE PROSCAN GREEN; OPHTHALMIC LASER

Model Number	LP6G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Retinal Tear (2050)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, there was an alleged unexpected power increase reported from a hospital in (b)(6) during prp treatment while using an integre proscan green unit, causing a retinal tear/break in a patient eye.This report is made by ellex without prejudice and does not imply any admission of liability for the incident or its consequences.
Additional Manufacturer Narrative
As soon as ellex was made aware of the event, the device performance was verified (b)(6) (b)(6) 2025), showing the equipment output power was in calibration with the set values on the user interface with nothing indicating that the equipment itself was in error.The device performance was verified as normal.Further investigation into device logs showed that no errors had been logged by the system and recorded that a change in power setting of 1500mw had occurred at the time of the recorded incident.There is a potential that the user may have unintentionally altered the power settings while making a non-power related adjustment on the system and missed noticing the power displayed on the user interface or understanding the audible tone during power change before firing.The user later performed retinopexy on this patient and another patient, with no consequences.Ellex has reviewed the labeling, risk controls and consider them adequate as the ifu warns the user to 'always select the lowest power and duration settings required to perform a procedure and to confirm the settign are correct before proceeding with the firing.' the device emits an audible beep confirming the change in value of the power, also indicated on the labeling.

• Brand Name: INTEGRE PROSCAN GREEN
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• Manufacturer (Section G): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• MDR Report Key: 21981994
• Report Number: 3002806902-2025-00001
• Device Sequence Number: 8553000
• Product Code: HQF
• UDI-Device Identifier: 09342395000243
• UDI-Public: (01)09342395000243(11)170316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K142398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Notification
• Type of Report: Initial
• Report Date (Section B): 05/06/2025

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: LP6G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2017
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male