MAUDE Adverse Event Report: IRIDEX CORPORATION MICROPULSE P3 DEVICE; MP3 PROBE

Model Number	15522
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to iridex that while using the micropulse p3 probe, the probe "popping sound occurred during treatment and probe burned out".No other additional information regarding this event was provided to iridex.This is a possible malfunction of the delivery device that may cause or contribute to a serious injury if the malfunction were recur.Iridex is investigating this complaint to gather more information of the even that occured.

• Brand Name: MICROPULSE P3 DEVICE
• Common Device Name: MP3 PROBE
• Manufacturer (Section D): IRIDEX CORPORATION; 1212 terra bella ave; mountain veiw CA 94043
• Manufacturer (Section G): IRIDEX CORPORATION; 1212 terra bella ave; mountain view CA 94043
• Manufacturer Contact: nimrta tandan ; 1212 terra bella ave; mountain view, CA 94043
• MDR Report Key: 19533944
• Report Number: 2939653-2024-00019
• Device Sequence Number: 15354538
• Product Code: GEX
• UDI-Device Identifier: 00813125016630
• UDI-Public: 00813125016630
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15522
• Device Lot Number: 870038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown