MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Seal Biopsy Valve; Endoscopic Irrigation/Suction System

Model Number	SBC-501
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a procedure performed on (b)(6) 2026.During the procedure, the biopsy cap detached from the scope while the biopsy forceps were being withdrawn.As a result, fluid leaked from the scope until the cap was reattached.The procedure was completed using the original device.There were no patient complications reported as a result of this event.
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.

• 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; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 25773599
• Report Number: 3005099803-2026-02743
• Device Sequence Number: 9633340
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• UDI-Public: (01)08714729981596
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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
• Device Catalogue Number: SBC-501
• Was Device Available for Evaluation?: No
• 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: 06/15/2026
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/24/2026
• 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