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

Model Number	797403
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction

• Brand Name: IntraSight
• 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: 50507580
• Report Number: 3008363989-2026-00147
• Device Sequence Number: 15817472
• Product Code: IYO
• UDI-Device Identifier: 00845225012878
• UDI-Public: (01)00845225012878(11)260108(10)1469759008
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 797403
• Device Catalogue Number: 797403
• Device Lot Number: 1469759008
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/28/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2026
• 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 Sex: Unknown