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	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0509 captures the reportable event of suction button sticking.Block e1 phone number: (b)(6).
Event or Problem Description
It was reported to boston scientific corporation that orca button was used during procedure performed on (b)(6) 2026.The suction button could no longer be pressed.The procedure was completed using with another of the same device.There were no patient complications reported as a result of this event.

• 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 ; +1(914)571-6918
• MDR Report Key: 25319714
• Report Number: 3005099803-2026-02157
• Device Sequence Number: 21332766
• Product Code: ODC
• UDI-Device Identifier: 00840253111012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160403
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 0036325092
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2025
• 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