MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE? ProKnife; unit, electrosurgical, endoscopic (with or without accessories)

Model Number	M00519351
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in an endoscopic submucosal dissection (esd) procedure performed on (b)(6)2026.During procedure, there was a problem with the electrical conduction.The procedure was completed with a different device.There were no patient complications as a result of this event, and the procedure was completed with a different device.
Additional Manufacturer Narrative
Block h6: imdrf device code f2301 captures the reportable event of device failure to deliver energy.

• 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; business and technology park,; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50912680
• Report Number: 3005099803-2026-03939
• Device Sequence Number: 5394472
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K200404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 0038137943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Date Device Manufactured: 11/10/2025
• 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