MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RADIAL JAW 4; FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number	1518
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: device code a051104 captures the reportable event of jaws failure to close.Device code a150208 captures the reportable event of forceps stuck inside the patient.Patient code e0750 captures the reportable event that the patient was intubated.Impact code f0801 captures the reportable event of patient admitted to the icu.Impact code f23 captures the reportable event that the patient required mechanical ventilator.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used in the lungs during a bronchoscopy procedure performed on an unknown date.During procedure, the jaws of the radial jaw 4 would no longer close on the fifth removal of specimen for biopsy.As it was risky to remove the forceps, the patient was intubated to await the arrival of the thoracic surgeon for conduct.The patient required mechanical ventilation and was admitted to the intensive care unit (icu).

• Brand Name: RADIAL JAW 4
• Common Device Name: FORCEPS, BIOPSY, BRONCHOSCOPE (NON-RIGID)
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23372968
• Report Number: 3005099803-2025-05629
• Device Sequence Number: 21056371
• Product Code: BWH
• UDI-Device Identifier: 08714729792864
• UDI-Public: (01)08714729792864(17)251011(10)30333123
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K252921
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2025
• Device Model Number: 1518
• Device Catalogue Number: 1518
• Device Lot Number: 0030333123
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/23/2025
• Date Device Manufactured: 10/12/2022
• 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 Sex: Unknown