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

Model Number	M00515201
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was to be used in the airway during a bronchial examination procedure performed on (b)(6) 2025.During preparation, the radial jaw 4 could not grab.The procedure was completed with another same device.There was no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 pulmonary biopsy forceps was to be used in the airway during a bronchial examination procedure performed on (b)(6) 2025.During preparation, the radial jaw 4 could not grab.The procedure was completed with another same device.There was no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name is (b)(6) hospital.Block h2: correction to block d4 model number.Block h6: imdrf device code a051104 captures the reportable event of jaws failure to close.Block h11: the returned radial jaw 4 was analyzed, and a visual inspection observed the clevis arms were bent.Microscope inspection found the wires were in good condition.Due to the bent clevis arms, the device could not actuate properly.Based on all available information, the reportable event jaws failure to close was confirmed.It was found that the clevis arms were bent preventing the jaws to close properly.It is possible that due to the manipulation or technique used at the time to remove the distal end cap could have damaged the distal part.Also, it is possible that due to operational factors such as the size of the desired biopsy and the force applied to the device in order to grasp the tissue, could have caused the analyzed failure.This is because the force applied to the handle in order to grasp the tissue could generate tension forces on the distal section that could have induced the damage found.Excessive manipulation of the device in or out of its pouch without enough care could have induced the defect found as well.Therefore, the most probable root cause is "adverse event related to procedure".

• 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: 23551359
• Report Number: 3005099803-2025-05923
• Device Sequence Number: 21276055
• Product Code: BWH
• UDI-Device Identifier: 08714729793281
• UDI-Public: (01)08714729793281(17)260814(10)32222596
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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 Expiration Date: 08/14/2026
• Device Model Number: M00515201
• Device Catalogue Number: 54940
• Device Lot Number: 0032222596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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 Age: 45 YR
• Patient Sex: Male
• Patient Weight: 82 KG