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

Model Number	M00513402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used in the upper and lower gi during a biopsy procedure.During the procedure, unexpected, severe bleeding occurred after the biopsy.The bleeding was treated by clipping and hemostasis-injection.The procedure was completed using the original device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6)2026 first day of the month as no event was reported.Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf impact code f2301 captures the reportable event of additional device required.

• 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; 2546 calle primera; alajuela
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50602481
• Report Number: 3005099803-2026-03523
• Device Sequence Number: 13401758
• Product Code: FCL
• UDI-Device Identifier: 08714729778028
• UDI-Public: (01)08714729778028(17)290426(10)39199214
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 10/02/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00513402
• Device Catalogue Number: M00513402
• Device Lot Number: 0039199214
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/04/2026
• Supplement Report FDA Received Date: 10/02/2026
• Date Device Manufactured: 04/27/2026
• 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