MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCA?; ENDOSCOPE CHANNEL ACCESSORY

Model Number	SUV-617-50
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that ten orca valves were used during an esophagogastroduodenoscopy (egd) procedure for the treatment of gerd on (b)(6) 2026.During the procedure, the physician observed that the red suction button became stuck in the depressed position after insertion.The physician attempted to remove and reinsert the button several times, but the issue persisted.A new pack of buttons of the same type was then opened and used to complete the procedure.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.Block h11: at this time the device is currently undergoing technical analysis.The investigation is not yet complete.A supplemental report will be submitted once the results are available.Block h7, h9, h11 on (b)(6) 2026, boston scientific initiated a field safety corrective action (fsca - boston scientific reference: (b)(4)) that included the removal of orca? single use air/water and suction valves associated with batch number 38400303 due to increased reports of suction button sticking issues.A communication was sent out to materials managers/health care professionals on (b)(6) 2026, with instructions to immediately stop further use or distribution of orca? single use air/water and suction valves associated with batch number 38400303, remove the devices from inventory, and segregate them in a secure location until they can be returned to boston scientific.Boston scientific will continue to closely monitor and trend similar events and associated risks, as outlined in our quality systems process.

• Brand Name: ORCA?
• Common Device Name: ENDOSCOPE CHANNEL ACCESSORY
• 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: 25301770
• Report Number: 3005099803-2026-02140
• Device Sequence Number: 9319640
• Product Code: ODC
• UDI-Device Identifier: 00840253111012
• UDI-Public: (01)00840253111012(17)290120(10)38400303
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K160403
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2026

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-617-50
• Device Catalogue Number: SUV-617-50
• Device Lot Number: 0038400303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 05/27/2026
• Supplement Report FDA Received Date: 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-05112026-002-
• Patient Sequence Number: 1
• Patient Sex: Unknown