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

Model Number LT5106-T

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

As soon as ellex inc (b)(4) (ellex medical subsidiary in (b)(4)) was notified of the event, the device was quarantined and the complaint notified to ellex medical.The service technician found the joystick wire was damaged.It was understood from the communication that the device was part of the recall in 2007 as per global service bulletin - 07-08.3 to add the retaining clip in the field, but apparently the modification was not carried out for this unit, as confirmed by the rework records.The reported "misfiring" must have occurred when the damaged wire made contact with the earthed joystick chassis in ready mode.The communication with the fda dated 5th july 2018 has not indicated any concerns of the effectiveness of the recall.As per the recall strategy detailed in the global service bulletin 07/08.3 | 24 august 2007 field correction was to be conducted at the next service call for each identified system.It is assumed that the customer did not arrange the preventive maintenance as they should have, or the recall was probably followed only for the 1st stage , and implementation was not followed up for the 2nd part of the recall (affixing of the retainer clip) which explains the reason for the missing retaining clip from this unit.As mentioned, there was no serious injury reported as the device was used for iridotomy and had caused minor injury to corneal endothelial cells not requiring medical intervention.However, the hazard severity could have been greater for other treatment procedures and there could have been a potential for a serious injury requiring medical intervention.Hence ellex considers it obligatory to report the incident.(b)(4).

Event Description

The user reported an unintended laser emission when moving the slit lamp with the joystick on a tango laser.There was minor injury to the corneal endothelial cells , which did not impact patient vision.

• Brand Name: TANGO
• Type of Device: 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: 9914734
• MDR Text Key: 208346351
• Report Number: 3002806902-2020-00003
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• PMA/PMN Number: K021550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/04/2020,04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT5106-T
• Was Device Available for Evaluation?: No
• Device Age: 13 YR
• Date Report to Manufacturer: 03/04/2020
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NUMBER NOT AVAILABLE
• Patient Sequence Number: 1
• Patient Outcome(s): Other