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

Model Number	M00519351
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the large bowel during a submucosal dissection procedure on (b)(6) 2024.During the procedure, orise electrode injection lumen got clogged, unable to supply solution.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 had detached from the device.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf result code c070603 captures the reportable investigation analysis of electrode detached.Block h11: investigation results the returned orise proknife was returned and analyzed.The device was returned without any visible failure.However, a functional inspection was performed by actuating the device, and it was noted that the electrode had detached from the device as it was not returned.The reported event was not confirmed; however, the device returned without the electrode.Based on the available information, the investigation findings of the detached electrode were most likely due to procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition.Therefore, a review and analysis of all available information indicated the most probable root 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22035192
• Report Number: 3005099803-2025-02218
• Device Sequence Number: 13144208
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: 08714729999881
• 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): 05/16/2025

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: 03/10/2026
• Device Model Number: M00519351
• Device Catalogue Number: M00519351
• Device Lot Number: 0034030003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2024
• 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