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

Model Number	M00519351
Medical Device Problem Codes	Failure to Cut (2587); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of electrode detached.Block h11: the returned orise proknife was analyzed, and a product analysis found the catheter was kinked.Functional inspection observed the electrode was broken and detached.The reported event of device failure to cut could not be confirmed.Based on all available information, it is likely that procedural factors, such as the length of time, power settings, handling technique, and tissue composition led to the damage of the electrode and subsequent use caused the electrode to detach.The kinks found on the catheter is likely due to the way in which the device was handled and manipulated during the procedure.Excessive manipulation of the device without enough care could have induced the defect found.Therefore, the most probable conclusion is adverse event related to procedure.Reported event of device failure to cut will be classified as cause not established due to this failure happened during the procedure and there is no objective evidence or descriptive conditions to establish the most probable cause.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the rectal/sigmoid during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2025.The procedure started at 9:45 am.The physician used a technique where a knife cuts in retracted position in locations where there is a higher risk of perforation.The knife also cuts with the needle extended.There had been multiple device exchanges with a coag grasper.At around 11am, the physician noticed that the knife no longer cuts in the retracted position.The proknife was removed and cleaned thoroughly with both an alcohol wipe to remove eschar and using the built-in needle cleaner with the needle retracted.Neither of these resolved the issue and the needle could not be used to cut in the retracted position for the remainder of the case.It could also be seen that the silver part of the needle could no longer been seen when retracted.It was also noted at around 11am that there was a kink in the catheter.The procedure was completed with this device.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation finding of electrode detached.Please see block h11 for full investigation details.

• 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: 21750694
• Report Number: 3005099803-2025-01311
• Device Sequence Number: 8263782
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: (01)08714729999881(17)250412(10)33415661
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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: 04/12/2025
• Device Model Number: M00519351
• Device Catalogue Number: M00519351
• Device Lot Number: 0033415661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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