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

Model Number	LT5106-T
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ellex has been made aware that following the incident , the user facility removed the ellex laser on (b)(6) 2020 to their head office in (b)(6) and is now at the distributor workshop.A technician would be sent for investigation and repair, but with the present lockdown in (b)(6), it has been a challenge for the service technicians to access the unit.
Event or Problem Description
There was an incident reported on the ellex tango laser machine(s/n: (b)(4)) used in an (b)(6) eye clinic.The users have indicated that the incident has adversely affected the patient's vision.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
Based on further information provided , the system was quarantined directly after the incident (b)(6) 2020 until the service technician verified that the system passed the service checks and there was no device fault which could have caused the incident.No further issues reported and system has been in use since 12.1.2021.As the device worked to specifications as verified by the product acceptance fault (paf) record, it can be concluded that the possible root cause of the incident was user error.The user may have used the incorrect mode ( slt instead of yag) for capsulotomy or probably a result from incorrectly targeting the treatment site.An evaluation of the labeling / device usability was done and it was deemed adequate.
Event or Problem Description
There was an incident reported on the ellex tango laser machine(s/n: (b)(6)) used in an ireland eye clinic.The users have indicated that the incident has adversely affected the patient's vision.This report is made by ellex without prejudice and does not imply any admission of liability for the incident or its consequences.

• Brand Name: TANGO
• Common Device Name: OPHTHALMIC LASER
• Manufacturer (Section D): ELLEX MEDICAL PTY LTD; 3-4 second avenue; mawson lakes, 5095 ; AS 5095
• MDR Report Key: 11183900
• Report Number: 3002806902-2021-00001
• Device Sequence Number: 3727236
• Product Code: HQF
• UDI-Device Identifier: 09342395000113
• UDI-Public: (01)09342395000113(11)171016
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K021550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: LT5106-T
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1