MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Radial Jaw 4; Forceps, Biopsy, Non-Electric

Model Number	M00513441
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used during an endoscopic biopsy procedure performed on (b)(6)2026.During the procedure, upon unpacking the device, white and thin fibers were found adhered to the distal cup when the protective tip cover was removed.The procedure was completed using another of the same device.There were no patient complications as the result of this event.
Additional Manufacturer Narrative
Block h11: imdrf device code (b)(6)captures the reportable event of device foreign material present in device.

• Brand Name: Radial Jaw 4
• Common Device Name: Forceps, Biopsy, Non-Electric
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50274599
• Report Number: 3005099803-2026-03352
• Device Sequence Number: 21478826
• Product Code: FCL
• UDI-Device Identifier: 08714729789918
• UDI-Public: (01)08714729789918(17)290319(10)38882886
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040447
• 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
• Report Date (Section B): 08/17/2026

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: M00513441
• Device Catalogue Number: M00513441
• Device Lot Number: 0038882886
• 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: 07/22/2026
• Initial Report FDA Received Date: 08/17/2026
• Date Device Manufactured: 03/20/2026
• 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