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	04/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used for the rectum in a rectal polyp removal procedure on (b)(6) 2026, for the treatment of rectal polyp.During the procedure, the physician noted a small black rubber fragment in the colon.The fragment was removed without issue and was identified as the inner portion of the orca biopsy cap that had become detached and fallen into the scope.The procedure was completed using the same device.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a040103 captures the reportable event of material fragmentation.Imdrf impact code f23 captures the reportable event of retrieval of the device.

• 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 ; +1(914)571-6918
• MDR Report Key: 25177201
• Report Number: 3005099803-2026-01905
• Device Sequence Number: 10692803
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• UDI-Public: (01)08714729981596
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 06/19/2026; 09/08/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 07/14/2026; 09/28/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown