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

Model Number	M00513331
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	01/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf e2114 captures the reportable event of perforation.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 large capacity forceps was used during a gastroscopy and colonoscopy procedure performed on (b)(6) 2025.During the procedure, the forceps completely removed the mucosa and submucosa, with a 4 mm punch specimen.The biopsy site was lost necessitating an exploration of the duodenum for 20 minutes, but the site was lost.This led to several postoperative complications, including pain, the need for a ct scan, nasogastric tube placement, prolonged fasting in an undernourished patient, and antibiotic treatment, ultimately extending hospitalization by three days.Ct findings suggest the presence of a few extra digestive air bubbles, notably periduodenal, perivesicular, and suprahepatic, associated with a small amount of intraperitoneal fluid in the douglas pouch, indicating a post-biopsy digestive perforation.The patient was given morphine for pain management.For antibiotic therapy, the patient was given rocephin and flagyl for 7 days.The patient's condition improved, and they were discharged to a rehabilitation center on february 3, 2025, with no further follow-up needed related to the event.

• 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 ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21591708
• Report Number: 3005099803-2025-00884
• Device Sequence Number: 18209262
• Product Code: FCL
• UDI-Device Identifier: 08714729648819
• UDI-Public: 08714729648819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 03/13/2025

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: M00513331
• Device Catalogue Number: 1333-20
• 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: 02/15/2025
• Initial Report FDA Received Date: 03/13/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female