MAUDE Adverse Event Report: IRIDEX CORPORATION OCULIGHT GLX; LASER, OPHTHALMIC

Catalog Number 26124

Device Problem Device Inoperable (1663)

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

Event Date 08/18/2015

Event Type  malfunction  

Event Description

Two new iridex lasers were acquired by the operating room and checked by biomedical engineering and placed into service.Vendor informed the team that no additional inservice training was required as the newer model operated similarly to the older model.Vendor representative presence was requested in the or for the first time use.No vendor available.Vendor representative communicated that the new lasers operated the same as the old lasers which was later learned to be incorrect while the surgeon was attempting to operate the device on a patient undergoing the procedure.The design in both models included a 'smart key' with key hole located on device.The older model required a 'smart key' to function properly while the new laser did not require activation of the device with use of a 'smart key'.The keys assigned to the new and older models were interchangeable.The smart key of the older model was placed into the new model which rendered the new laser inoperable.During the procedure, the vendor was unavailable and unable to troubleshoot or identify the cause for the device performance failure in the new laser.The older version was returned to the operating room and used for this case after the new laser was not performing as intended.The user manual does not address the purpose of the smart key and safe use.

• Brand Name: OCULIGHT GLX
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella avenue; mountain view, ca CA 94043
• MDR Report Key: 5155475
• MDR Text Key: 28454215
• Report Number: 5155475
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2015,09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 26124
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 56 YR