MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX Needle Knife XL; Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Model Number	M00545840
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two rx needle knife xl used in the same procedure.It was reported to boston scientific corporation that an rx needle knife xl was used in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat biliary stones performed on (b)(6) 2026.During the procedure, it was reported that the needle knife was bent and having an orientation problem.A second rx needle knife xl was used, and the needle knife was bent and the tip was damage.The procedure was completed with a third rx needle knife xl.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a040601 captures the reportable event of cutting wire kinked.Block h11: investigation results the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.With all the available information, boston scientific concludes that the reported event of wire kinked could not be confirmed.The device was not returned for analysis because it was disposed.Without analysis of the actual device, there is a lack of objective evidence, or descriptive conditions of the event required to determine a probable root cause of the event.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.A similar complaint review was completed.There were no emerging trends identified that warrant further action.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• Brand Name: RX Needle Knife XL
• Common Device Name: Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
• 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 ; +1(914)571-6918
• MDR Report Key: 50798996
• Report Number: 3005099803-2026-03825
• Device Sequence Number: 18794199
• Product Code: KNS
• UDI-Device Identifier: 08714729283799
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K973826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: M00545840
• Device Catalogue Number: M00545840
• Device Lot Number: 0037211485
• 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: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 08/14/2025
• 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