MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MICROKNIFE XL; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00532810
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the reported initial reporter's address is no.(b)(6); reported here as initial reporter address 1 exceeded the character limit for the designated field.Block h6: imdrf device cod a040601 captures the reportable event of wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after the microknife was inserted into the duodenal scope and extended out of the working channel, they noticed that the knife tip was already bent when it emerged.The procedure was completed with different device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the reported initial reporter's address is (b)(6); reported here as initial reporter address 1 exceeded the character limit for the designated field.Block h11 (correction): block b5 (describe event or problem) has been updated.Block h6: imdrf device code a040601 captures the reportable event of wire kinked.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the duodenal and papilla performed on (b)(6) 2025.During the procedure, after the microknife was inserted into the duodenal scope and extended out of the working channel, they noticed that the knife tip was already bent when it emerged.The procedure was completed with different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: MICROKNIFE 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 ; 9145716918
• MDR Report Key: 23962181
• Report Number: 3005099803-2026-00019
• Device Sequence Number: 9406043
• Product Code: KNS
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K973826
• 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,Followup
• Report Date (Section B): 05/19/2026

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: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0035149982
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 04/21/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 01/28/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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