MAUDE Adverse Event Report: Volcano Corporation IntraSight Mobile System; System, Imaging, Pulsed Echo, Ultrasonic

Model Number	797415
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction

• Brand Name: IntraSight Mobile System
• Common Device Name: System, Imaging, Pulsed Echo, Ultrasonic
• Manufacturer (Section D): Volcano Corporation; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer (Section G): Volcano Corporation; 3721 valley centre drive #500; san diego CA 92130
• Manufacturer Contact: ayse kharodawala ; 3721 valley centre drive #500; san diego, CA 92130 ; +1(858)720-4063
• MDR Report Key: 50824671
• Report Number: 3008363989-2026-00154
• Device Sequence Number: 15984531
• Product Code: IYO
• UDI-Device Identifier: 00845225012915
• UDI-Public: (01)00845225012915(11)220603(10)1420189
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203719
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 797415
• Device Catalogue Number: 797415
• Device Lot Number: 1420189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Age: 82 YR
• Patient Sex: Male