MAUDE Adverse Event Report: ALCON ALCON LASER PROBE; LASER OPHTHALMIC

Model Number 8065751592

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 02/21/2018

Event Type  malfunction  

Event Description

Laser probe hooked up to machine.Attempted use.Discovered that probe cord was broken.

• Brand Name: ALCON LASER PROBE
• Type of Device: LASER OPHTHALMIC
• Manufacturer (Section D): ALCON; fort worth TX 76134
• MDR Report Key: 7316872
• MDR Text Key: 101839769
• Report Number: MW5075686
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• 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: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 8065751592
• Device Catalogue Number: 8065751592
• Device Lot Number: 17023042X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 60