MAUDE Adverse Event Report: ALCON STAND LX3; RETROFIT

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2015

Event Type  Injury  

Event Description

Brand new never used before equipment shut down after patient was prepped and ready for surgery.Incision to eye was made and scope was ready to be used when it gave an error message of 403.Spoke to rep at the time stating that this is something that cannot be fixed over the phone and that the procedure would have to be cancelled and rep/tech would have to come out next day to fix problem.Patient had anesthesia, recovery and post-op visit for a procedure that was not even completed.She had to return to have the procedure done again.

• Brand Name: STAND LX3
• Type of Device: RETROFIT
• Manufacturer (Section D): ALCON
• MDR Report Key: 4949699
• MDR Text Key: 6196687
• Report Number: MW5044866
• Device Sequence Number: 1
• Product Code: HRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Weight: 68