MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORCAPOD?; PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Model Number	SUV-633
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a050401 captures the reportable event of the a/w valve fluid leak.
Event or Problem Description
It was reported to boston scientific corporation that an orcapod was used during a colonoscopy procedure in the colon for the treatment of polyps performed on (b)(6) 2025.It was reported that the blue air/water button was leaking water after being installed on the scope.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: ORCAPOD?
• Common Device Name: PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE
• 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: 22726732
• Report Number: 3005099803-2025-03714
• Device Sequence Number: 9143993
• Product Code: FEQ
• UDI-Device Identifier: 08714729991144
• UDI-Public: (01)08714729991144(17)280403(10)36228202
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/06/2025

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-633
• Device Catalogue Number: SUV-633
• Device Lot Number: 0036228202
• 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: 07/11/2025
• Initial Report FDA Received Date: 08/06/2025
• Date Device Manufactured: 04/04/2025
• 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