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

Model Number LQP3106-U

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

As soon as ellex became aware of the event , the device was quarantined and based on the device details , the unit was traced to the 2007 recall , which was reiterated in 2020.The correction was not carried out for this unit , which has resulted in the unintended laser firing.The event was reported to fda under 21cfr1003 in 2020 and corrective action plan was done in accordance with 21 cfr 1004.This unit has been decommissioned for further use.

Event Description

An unintended laser firing has been reported in germany for a pending 2007recall unit of ultraq.There was no patient involved , no injury reported.

• Brand Name: ULTRAQ
• 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
• MDR Report Key: 18892087
• MDR Text Key: 337548715
• Report Number: 3002806902-2024-00001
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• PMA/PMN Number: K212630
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LQP3106-U
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: COR21000397
• Patient Sequence Number: 1
• Patient Outcome(s): Other