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

Model Number	15980
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	02/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting a patient experiencing conjunctival burn during treatment with the cyclo g6 laser system in combination with g-probe.The treatment was performed within specifications.Engineering failure analysis was performed on the returned laser system.The investigation and testing did not replicate a power surge.It was observed that the power values were below specification.The low power condition does not appear to be a contributing factor for this incident.Iridex has requested the clinic to return the g-probe associated used during treatment.A specific root cause could not be determined at this point and additional investigation will be performed if the probe is returned.
Additional Manufacturer Narrative
This follow-up report is provided to update the following: 1)part b: b5 -product problem section was updated.2) report c: is this a combination product - no.3) report d: updates to section d8, d9, d4.4) part h: update to include that this a correction, additional information, device evaluation report.5) part d: updated this section with the udi number.6) part e: updates to the initial reporter section with information regarding the complainant.Note: patient information was not provided, therefore part a is not filled out.
Event or Problem Description
Iridex became aware of a complaint reporting a patient experiencing conjunctival burn during treatment with the cyclo g6 laser system in combination with g-probe.The treatment was performed within specifications.Engineering failure analysis was performed on the returned laser system(console and probe).The investigation and testing of the console did not replicate a power surge, with laser console power values not above specification, therefore it can be confirmed that the system did not deliver excess laser energy.The returned probe was investigated and the presence of contamination was confirmed on the probe tip.Based on the information provided by the complainant and investigation of the returned products performed by iridex, the most likely cause of the burn was determined to be use of the device after the device tip was contaminated with blood.The g-probe ifu provides instructions to the user to "keep the g-probe tip clean to minimize the risk of burns to the ocular surface." the ifu contains the warning that "contamination of the fiber optic tip by blood or tissue char may result in ocular surface burns." the complainant reported that no malfunction of the laser console and delivery device was observed.No other information was provided regarding the patient's post-procedural status.

• 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 94043-9149 ; 6502189149
• MDR Report Key: 13830911
• Report Number: 2939653-2022-00007
• Device Sequence Number: 910618
• Product Code: HQF
• UDI-Device Identifier: 00813125015220
• UDI-Public: 0813125015220
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/24/2024

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: 900611
• 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: Not provided
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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