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

Model Number	M00513363
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6).Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used in a procedure performed on (b)(6) 2026.During the procedure, when the jumbo forceps was pulled out from the endoscope, it appeared to be caught in the area where it will be inserted into forceps channel and could not be pulled out.Insertion and pulling out operation were repeatedly performed several times, but it still could not be removed.The procedure was not completed due to this event.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of aborted procedure.Block h11: the device was not returned for analysis; therefore, a product analysis could not be performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the event description and information provided by the customer, there is not enough evidence to determine whether the issues were induced due to the physician's technique during the procedure or were related to a device malfunction.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issues cannot be established due to lack of evidence.Without the device, it remains unknown the causes that contributed to the events.Finally, the event cancelled/rescheduled - post sedation/sedation unknown will be classified as cause not established since there is not enough information to clarify the reason why of this condition.All compiled information on this investigation determines that the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a radial jaw 4 was used in a procedure performed on (b)(6) 2026.During the procedure, when the jumbo forceps was pulled out from the endoscope, it appeared to be caught in the area where it will be inserted into forceps channel and could not be pulled out.Insertion and pulling out operation were repeatedly performed several times, but it still could not be removed.The procedure was not completed due to this event.No patient complications were reported as a result of this 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24987605
• Report Number: 3005099803-2026-01512
• Device Sequence Number: 10451007
• Product Code: FCL
• UDI-Device Identifier: 08714729761914
• UDI-Public: (01)08714729761914(17)280831(10)37341577
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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 Model Number: M00513363
• Device Catalogue Number: M00513363
• Device Lot Number: 0037341577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 09/01/2025
• 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
• Patient Sex: Unknown