MAUDE Adverse Event Report: IRIDEX CORPORATION G-PROBE; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number 15980

Device Problem Use of Device Problem (1670)

Patient Problem Eye Burn (2523)

Event Date 08/24/2022

Event Type  Injury  

Event Description

Iridex became aware of a patient experiencing a scleral burn during treatment with a cyclo g6 laser system in combination with a g-probe delivery device.Engineering failure analysis was performed and the presence of burnt particle was identified on the probe tip.The activation of laser with the presence of burnt particle on the fiber channel is the root cause for this adverse event.However; per the ifu, 'scleral burns are not typical and may indicate contamination at the device tip.The ifu also instructs the user to discontinue use and replace the device immediately if a scleral burn occurs.The fact that multiple burns were reported suggests that the device tip became contaminated with tissue or blood during use and that the contamination was'nt observed and the treatment was continued.The g-probe ifu provides instructions for maintaining cleanliness of the device tip and related cautions on page 1' keep the device tip clean to minimize the risk of burns to the ocular surface.If the tip accumulates debris or "charring"during the procedure, clean it gently with an alcohol swab.If the "charring" or discoloration on the tip cannot be removed by gentle cleaning, discard the device.The ifu also contains a warning regarding potential harm that may result from use of a device with contamination on the fiber optic tip and activating the laser in areas with prelimbal conjunctival pigmentation.Contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns.Heavy perilimbal conjunctival pigmentation may result in local absorption and burns; therefore, avoid areas of heavy perilimbal pigmentation.Iridex will continue to follow-up with the facility regarding the recovery of the patient.

• Brand Name: G-PROBE
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave.; mountain view CA 94043 1824
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043 9149
• Manufacturer Contact: madhumita srikanth ; 1212 terra bella ave.; mountain view, CA 94043-1824 ; 6502189149
• MDR Report Key: 15514187
• MDR Text Key: 300877565
• Report Number: 2939653-2022-00029
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15980
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other