MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE? PROKNIFE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00519361
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during procedure on (b)(6) 2026.During the procedure, the electrode became unable to retract.Another orise proknife was used to complete the procedure.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results; the electrode was broken/separated.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the investigation analysis of electrode detached.Block h11: investigation results: the orise proknife was returned for analysis.Visual and microsope analysis revealed that the catheter was kinked, and the electrode was broken/separated.Based on the available information, this issue likely has occurred due to procedural factors, such as the length of time that the device was used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage.Subsequent use of the electrode resulted in the break/separation of the component.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• Brand Name: ORISE? PROKNIFE
• 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 LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24708314
• Report Number: 3005099803-2026-01121
• Device Sequence Number: 18669408
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: (01)08714729999898
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200404
• 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): 03/26/2026

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: M00519361
• Device Catalogue Number: M00519361
• Device Lot Number: 37185227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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