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

Model Number	SBC-501
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orcapod 4 was used during a procedure performed on (b)(6), 2026.During the procedure, the middle section of the biopsy bung has detached and become lodged in the channel port, causing an obstruction in the working channel of the scopes.There were no patient complications reported as a result after this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6: imdrf device code a040103 captures the reportable event of seal biopsy valve material fragmentation.

• 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 dr; baldwin WI 54002
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50202750
• Report Number: 3005099803-2026-03254
• Device Sequence Number: 17529143
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/11/2026
• 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