MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3; LASER INSTRUMENT, SURGICAL, POWERED, PRODUCT CODE: HQF

Model Number	15522
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure and reported the presence of burn rings on the patient's eye.The procedure was performed using a micropulse p3 probe and cyclo g6 laser system.A conclusive root cause for this event was not determined.The treatment settings were within specifications.Engineering failure analysis has not yet been performed because the returned probe has not been received.Failure analysis will be completed once the probe is received.If new information becomes available, this record will be amended.The results of post market data review indicate that this failure mode is not occurring with greater severity or frequency based on the number of events reported evaluated against the number of cases performed.
Event or Problem Description
Iridex became aware of a complaint reporting that the tip of the probe began emitting smoke during the procedure and reported the presence of white burn rings on the patient's eye.The procedure was performed using a micropulse p3 (mp3) probe and cyclo g6 laser system.The treatment settings were within specifications.The doctor indicated the no prior surgeries were performed on the patient.The mp3 probe began to smoke and it was reported that the probe tip turned black during the procedure.The surgeon immediately stopped the procedure.Based on the information provided by the complainant, the most likely cause of the burn was determined to be use of the device after the device tip has become contaminated.Likely source of contamination was blood, tissue or betadine.The micropulse p3 ifu contains instructions for inspecting and cleaning the device tip during use, and the ifu contains the warning that "contamination of the device tip with blood or tissue of the fiber optic by blood or tissue char can result in surface burns in the eye.As per the ifu " if the probe tip accumulates debris or "charring" during the procedure, clean it gently with sterile gauze and a saline solution.Keep the device clean to minimize the risk of burns to the ocular surface.After cleaning tip, re-apply a drop of methylcellulose geland continue treatment.If the "charring" or discolorationon the tip cannot be removed by gentle cleaning, discard the device".
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 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: information regarding age and sex of the patient has been provided and updated.

• Brand Name: MICROPULSE P3
• 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: 14740053
• Report Number: 2939653-2022-00018
• Device Sequence Number: 4843791
• Product Code: HQF
• UDI-Device Identifier: 00813125015251
• UDI-Public: 813125015251
• 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): 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: 15522
• 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: 06/18/2022
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 73 YR
• Patient Sex: Male