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

Model Number	M00519351
Medical Device Problem Codes	Mechanical Problem (1384); 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	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable investigation analysis of electrode detached.Block h11: investigation results an orise proknife was received for analysis.Visual inspection identified that the catheter was kinked.Functional and microscopic examination determined that the device was returned without the electrode attached.The reported event could not be confirmed based on the available evidence.However, it is likely that procedural factors, such as the duration of use, power settings applied, handling technique, and/or tissue characteristics contributed to electrode damage.Continued use following the damage may have resulted in the electrode detachment.Based on the review of all available information, the most probable cause of the reported event is determined to be adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection (esd) procedure on an unknown date.During the procedure, it was observed that the electrode failed to protrude when the handle was operated to the midway position.The device was removed from use and replaced with another orise proknife 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 device returned without the electrode.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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24426612
• Report Number: 3005099803-2026-00693
• Device Sequence Number: 9840249
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: (01)08714729999881(17)270609(10)36996219
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: M00519351
• Device Catalogue Number: M00519351
• Device Lot Number: 0036996219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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