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); Failure to Fold (1255); Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section e: this event was reported by the distributor.The healthcare facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of wire break.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, when the device was opened and tested, the physician noted that the tip of the device did not respond accordingly to the opening and closing movement of the handle.The physician noted that the metal wire that connects the handle to the tip of the device was broken.The device was not used to complete the procedure.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During preparation, when the device was opened and tested, the physician noted that the tip of the device did not respond accordingly to the opening and closing movement of the handle.The physician noted that the metal wire that connects the handle to the tip of the device was broken.The device was not used to complete the procedure.No further information has been obtained despite good faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Section e: this event was reported by the distributor.The healthcare facility is: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of wire break.Block h11: (investigation result) the returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was kinked and broken at handle section which causes the needle unable to extend.The transition was also bent.Microscopic evaluation of the distal section shows the cutting wire was found in good condition.No other problems with the device were noted.The reported event of cutting wire break was confirmed.Upon analysis, it was found that the cutting wire was kinked and broken at handle section and the transition kinked.The condition could have occurred as part of the device manipulation during the procedure, an excess of force was applied to the device such as during the device insertion/removal, through/from another device or by the interaction with the scope (hard surface).The kink can generate increased friction between the wire and the transition, causing the wire to become stuck or not be able to be moved 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.

• 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: 21315864
• Report Number: 3005099803-2025-00306
• Device Sequence Number: 8564128
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Expiration Date: 05/02/2026
• Device Model Number: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0033956425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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: 70 YR
• Patient Sex: Male