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	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip broke.
Event or Problem Description
Note: this report pertains to two of two devices used during the same procedure.Refer to manufacturer report number 3005099803-2025-0494 for the first orise proknife, and 7 for the second orise proknife.It was reported to boston scientific corporation that an orise proknife was used in rectum during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2025.During the procedure, two orise proknives broke and could not be extended.The procedure was completed using a different device from another model and manufacturer.There were no reported patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in rectum during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2025.During the procedure, the tip of two orise proknife devices broke and could not be extended.The procedure was completed using a different device from another model and manufacturer.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip broke.Block h11: investigation results.The returned orise proknife was received for analysis.Visual and microscope examination revealed that the catheter was kinked and that the device returned without the electrode.The reported event was confirmed.Based on the available information, the investigation findings were likely that procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage, and subsequent use of the electrode resulted in the detachment.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 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: 23309810
• Report Number: 3005099803-2025-04946
• Device Sequence Number: 4989040
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: (01)08714729999881(17)270624(10)37061580
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 01/19/2026

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: 0037061580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• 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