MAUDE Adverse Event Report: ELLEX MEDICAL PTY. LTD.; POWERED LASER SURGICAL INSTRUMENT

Device Problem Activation Failure (3270)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

Once patient was positioned for a yag laser capsulotomy procedure, it was discovered that the laser guidance red light was not working.Without a red dot, the physician does not know where the laser beam is going.Physician cancelled the case and will reschedule.No patient harm.

• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ELLEX MEDICAL PTY. LTD.; 7138 shady oak road; eden prairie MN 55347
• MDR Report Key: 15198135
• MDR Text Key: 297593260
• Report Number: 15198135
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Date Report to Manufacturer: 08/10/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA