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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation result of cutting wire break.Block h11: investigation results the returned microknife xl was analyzed, and a visual inspection found no visible damages to the device initially.Functional test was performed, and the device was actuated, and the needle was not able to extend.Destructive test was performed, and the device was dissembled and was found that the cutting wire was blacked and broken, due to this condition the needle was unable to extend.No other problems with the device were noted.The results of the analysis performed on the returned device found that the needle (cutting wire) was broken and blackened.Based on this condition it can be determined that current was applied to the device, it is likely that the technique used, the patient anatomy, interaction with the scope or additional devices, also if it has exceeded the maximum of voltage or if the cutting wire was not in constant motion, therefore these procedural factors could have contributed to the broken wire leading to an extension problem as well due to the missing broken section.The investigation findings and all information available concludes the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was attempted to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stone performed on (b)(6) 2025.During the procedure, when the power supply was connected and the elytrotomy was prepared, the cutting wire of the tome could not come out.The procedure was completed with another microknife xl.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 stable.This event has been deemed a reportable event based on the investigation finding of a cutting wire break.Please see block h11 for full investigation details.

• 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: 24217828
• Report Number: 3005099803-2026-00358
• Device Sequence Number: 18164128
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)261008(10)35022377
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: 0035022377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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 Age: 64 YR
• Patient Sex: Male
• Patient Weight: 73 KG