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

Model Number	SUV-629-50
Medical Device Problem Codes	Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that orca valve was used during a procedure performed on unknown date.During the procedure, the air/water button was leaking water and not providing enough insufflation.The procedure was completed using with another of the same device.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 h6: imdrf device code a050401captures the reportable event of air water button leaking.

• 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: 25333515
• Report Number: 3005099803-2026-02199
• Device Sequence Number: 15860450
• Product Code: ODC
• UDI-Device Identifier: 08714729981589
• UDI-Public: (01)08714729981589(17)280626(10)36853427
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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-629-50
• Device Catalogue Number: SUV-629-50
• Device Lot Number: 0036853427
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 07/13/2026
• Date Device Manufactured: 06/27/2025
• 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