MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE; ENDOSCOPIC IRRIGATION/SUCTION SYSTEM

Model Number	SBC-501-100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0504 captures the reportable event of seal biopsy valve leak/splash.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on (b)(6) 2026.During the procedure, fecal fluid backflow from the seal valve was observed.The procedure was completed using a device from a different manufacturer.There were no patient complications reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: ENDOSCOPIC IRRIGATION/SUCTION SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; nolato contour inc; baldwin WI 54002
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24434145
• Report Number: 3005099803-2026-00709
• Device Sequence Number: 10227375
• Product Code: OCX
• UDI-Device Identifier: 08714729981619
• UDI-Public: (01)08714729981619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: SBC-501-100
• Device Catalogue Number: 2235-01
• 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: 01/29/2026
• Initial Report FDA Received Date: 02/24/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown