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

Model Number	15980
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	08/30/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a patient experiencing burn marks 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 contamination could not be identified on the probe tip.The exact root cause is unknown.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 for additional information and patient follow up.
Event or Problem Description
Follow up report: part a is not filled out because patient identifier details (part a) were not provide to iridex.This report has been created to make corrections to the previous report.The changes include: 1) report c: is this a combination product - no.2) report d: updates to section d8, d9.3) part h: update to include that this a correction report.4) part d: update the lot number information.The lot number was filled out in the section for serial number.Updated this section with the udi number.5) part e: updates to the initial reporter section with infromation regarding the complainant.6) part h4: updates to date of manufacture.This infromation was not submitted previously.The following text were provided in the initial report: iridex became aware of a patient experiencing burn marks 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 contamination could not be identified on the probe tip.The exact root cause is unknown.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 for additional information and patient follow up.

• Brand Name: G-PROBE
• Common Device Name: 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: 15514539
• Report Number: 2939653-2022-00030
• Device Sequence Number: 17634872
• Product Code: HQF
• UDI-Device Identifier: 00813125016630
• UDI-Public: 00813125016630
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 15980
• Device Lot Number: 900774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown