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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
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 orise proknife could not be pushed out of the catheter.The procedure was completed using a different device from another manufacturer.There were no reported patient complications as a result of this event.This event has been deemed a reportable event based on the investigation results; the device was returned without the electrode.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code c070603 captures the investigation analysis of electrode detached.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 indicates that the findings were most likely related to procedural factors.Including but not limited to the duration of use.Power settings.Handling technique.And/or tissue composition, which may have contributed to electrode damage, subsequent use of the device resulted in electrode detachment.Therefore, based on a review and analysis of all available information, the most probable cause of the event is determined to be 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 LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24118424
• Report Number: 3005099803-2026-00248
• Device Sequence Number: 5941698
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: (01)08714729999881
• 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
• Report Date (Section B): 01/20/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Male