MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCAPOD?; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number	SUV-632
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6:.Imdrf device code a050401 captures the reportable event of a/w valve fluid/blood leak.
Event or Problem Description
It was reported to boston scientific corporation that an orcapod was used during a colonoscopy procedure performed for screening on (b)(6) 2025.During the procedure, the air/water button began leaking water after it was attached to the scope.They tried taking it off and putting it back on, however, the same problem occurred.The procedure was completed using this device.There were no patient complications reported as a result of this event.

• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22772681
• Report Number: 3005099803-2025-03963
• Device Sequence Number: 18463891
• Product Code: ODC
• UDI-Device Identifier: 08714729991137
• UDI-Public: (01)08714729991137(17)280102(10)35542162
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 08/11/2025

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-632
• Device Catalogue Number: SUV-632
• Device Lot Number: 0035542162
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/11/2025
• Date Device Manufactured: 01/02/2025
• 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