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

Model Number	M00532810
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384); 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	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the pre-cut needle failed to open after several successful openings and closings.On approximately the fourth or fifth attempt, the needle remained closed despite the nurse positioning it in the open state.The procedure was then completed using another device of the same model.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a cutting wire broken and kinked.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of cutting wire broken.Imdrf device code a040601 captures the reportable investigation results of cutting wire kinked.The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was kinked and broken at handle section.Additionally, the device was disassembled and was observed that the hypo tube was kinked.No other problems with the device were noted.The product analysis revealed that cutting wire was kinked and broken at handle section.Additionally, the hypo tube was kinked.The condition of hypo tube kinked could have been generated due to excess manipulation against the unit.It is most likely that as part of the device manipulation during the procedure an excess of force was applied to the device such as during the device insertion and removal through or from another device or by the interaction with the scope (hard surface).The kink generates increased friction between the wire and the hypo tube, causing the wire to become stuck and not able to move easily.With this friction, the handle actuation leads to breakage of the cutting wire at handle section, making the needle unable to extend.Based on all gathered information, the most probable root cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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: 24489609
• Report Number: 3005099803-2026-00777
• Device Sequence Number: 5016912
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)270704(10)36898585
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 03/02/2026

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: 0036898585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2025
• 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