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

Model Number	LP6Y
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
There was an incident reported on the ellex proscan laser used in a (b)(6) eye clinic.During photocoagulation for a retinal tear on a patient, bleeding occurred.
Additional Manufacturer Narrative
The doctor treated the bleeding with laser photocoagulation.The bleeding resolved without any complications after the photocoagulation.There was no device problem, the device was verified after the event, and it was within specifications.The device labelling and risk control measures were reviewed and considered adequate.According to the clinical expert, sometimes the laser breaks an inter retinal vessel and bleeding occurs.The energy discharge near the vessels sometimes may be a little high which can cause bleeding.

• Brand Name: PROSCAN
• 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
• Manufacturer Contact: rashmi pillay ; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• MDR Report Key: 14460237
• Report Number: 3002806902-2022-00002
• Device Sequence Number: 4504514
• Product Code: HQF
• UDI-Device Identifier: 09342395000168
• UDI-Public: (01)09342395000168(11)200518
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Notification,Inspection,Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/20/2022

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: LP6Y
• Device Catalogue Number: INTEGRESCAN-Y
• 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: 04/24/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2020
• 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 Age: 68 YR
• Patient Sex: Female