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

Model Number	LT5106-T
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	12/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As soon as ellex medical was made aware of the event as only an 'adverse effect' occurrence , ellex has been consistently following up with the practice to confirm whether an 'adverse event' did occur and the patient status.The information on serious injury was only made available today (17th feb).Device verification was performed on 17th jan and there was no fault found with the device.As confirmed by the physician ,the 1st laser shot was made with the wrong mode for capsulotomy (sltinstead of yag) which was the reason for the patient eye damage.Ellex also verified the adequacy of the existing design , labelling and risk controls and these were deemed to be adequate.Tango can operate in both the yag/slt mode.After each shot, the laser reverts to standby so that the treatment mode has to be selected each time before firing the next shot.Labelling emphasizes on checking the correct mode of operation for the laser procedures.
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.During yag capsulotomy, the doctor accidentally set the laser mode to slt instead of yag resulting inpatient eye damage.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
• 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: 13553211
• Report Number: 3002806902-2022-00001
• Device Sequence Number: 11876281
• Product Code: HQF
• UDI-Device Identifier: 09342395000113
• UDI-Public: (01)09342395000113(11)171016
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring,Inspection,Notification
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: LT5106-T
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 02/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• 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
• Patient Age: 71 YR
• Patient Sex: Female