MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCAPOD?; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SUV-633
Medical Device Problem Codes	Fluid/Blood Leak (1250); Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050401 captures the reportable event of a/w valve fluid leak.
Event or Problem Description
It was reported to boston scientific corporation that an orca pod was used in the common bile duct for the treatment of common bile duct stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, continuous over-irrigation, significant water leakage, excessive bubbling, and inadequate insufflation were observed, resulting in poor visualization and compromised imaging quality.The physician attempted to adjust the buttons (on and off), but this had no positive effect.The procedure was completed using a non-boston scientific device.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device code) imdrf device code a050401 captures the reportable event of a/w valve fluid leak.Block 11 the product was not returned for analysis; therefore, a technical evaluation could not be performed.However, the complainant provided a photo of the device, allowing for a media-based assessment.Upon inspection, the images showed poor visualization and compromised imaging quality.Nevertheless, they did not provide sufficient evidence to determine whether the orca device contributed to the reported issue.As the product was not available for physical analysis, the event could not be confirmed.Based on the information provided, the most probable cause of the reported issue cannot be determined due to insufficient evidence.Furthermore, without a proper evaluation of the device, the most probable cause contributing to the event remains unknown.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an orca pod was used in the common bile duct for the treatment of common bile duct stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, continuous over-irrigation, significant water leakage, excessive bubbling, and inadequate insufflation were observed, resulting in poor visualization and compromised imaging quality.The physician attempted to adjust the buttons (on and off), but this had no positive effect.The procedure was completed using a non-boston scientific device.No patient complications were reported as a result of this event.

• Brand Name: ORCAPOD?
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23189725
• Report Number: 3005099803-2025-04903
• Device Sequence Number: 9815782
• Product Code: OCX
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144(17)280529(10)36646084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: SUV-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 0036646084
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 05/30/2025
• 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
• Patient Sex: Unknown