MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OrcaPod?; endoscopic irrigation/suction system

Model Number	SUV-628
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Problem (2170); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that orca valve was used during an esophagogastroduodenoscopy (egd) procedure performed on an unknown date, for biopsy.During the procedure, the physician experienced an air/water button leak, a flow issue, and a suction problem.Despite these issues, the procedure was completed using the same device.The physician reported that the procedure was delayed as a result of these issues.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d2b: subsequent pro code odc block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a050401 captures the reportable event of air water button leaking.Block h11: investigation summary: based on the available information, boston scientific was unable to confirm the reported events of a/w valve fluid leak and suction valve suction issue because the device had been disposed of.However, an engineering review was conducted, it was determined that the flow issue/continuously routes water over lens was likely caused by inadequate material selection, geometry, and design verification of the orca 4-tab one way seal (ows) component.Device technical analysis: the device was not returned; therefore, technical analysis could not be performed.Investigation conclusion: this device was not returned for investigation.As such, physical analysis has not been conducted in our laboratory.However, an engineering review was conducted.This review determined that the (flow issue/continuously routes water over lens) was likely a result of inadequate material, geometry, and design verification of the orca 4-tab one way seal (ows) component.An investigation to address this problem is in progress.The root cause of the reported (suction valve suction issue/fluid leak) could not be established in absence of returned device analysis.

• Brand Name: OrcaPod?
• Common Device Name: endoscopic irrigation/suction system
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporat; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25874073
• Report Number: 3005099803-2026-02939
• Device Sequence Number: 8103548
• Product Code: OCX
• UDI-Device Identifier: 08714729981558
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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: SUV-628
• Device Catalogue Number: SUV-628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/22/2026
• 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