MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, NON-ELECTRIC

Model Number	M00513330
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Radial jaw/biopsy forceps placed down scope, not noted until presentation at end of scope a sliver of metal protruding from forceps grasper, immediately removed and new forceps used without further incident during case or harm to patient.

• 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
• MDR Report Key: 24220591
• Report Number: 24220591
• Device Sequence Number: 15475146
• Product Code: FCL
• UDI-Device Identifier: 08714729745549
• UDI-Public: (01)08714729745549(17)280616(10)36775889
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/20/2026
• Report Date (Section F): 01/20/2026

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
• Device Model Number: M00513330
• Device Catalogue Number: M00513330
• Device Lot Number: 36775889
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2026
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/20/2026