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	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital; reported here as the facility name exceeded character limit for the designated field.Initial reporter address 1: (b)(6); reported here as the address exceeded character limit for the designated field.Block h6: imdrf device code a0501 captures the reportable investigation result of electrode detached/separated.Block h11: investigation results.The returned orise proknife was received for analysis.Visual examination revealed that the catheter was kinked.During a functional inspection, it was observed that the device was missing an electrode, which prevented full functionality testing.The reported event could not be confirmed; however, the device was returned without the electrode.Based on the available information, investigation findings could not be established due to the absence of the electrode.Additionally, the catheter was found to be kinked.The kinks are likely the result of how the device was handled and manipulated during the procedure.Excessive or improper manipulation without sufficient care may have contributed to the observed damage.Therefore, after reviewing and analyzing all available information, the most probable cause is determined to be cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during procedure on (b)(6) 2025.During the procedure, the orise electrode was unable to move at all.The procedure was completed using another orise proknife.There were no patient complications as a result of this event.

• 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: 23327691
• Report Number: 3005099803-2025-05027
• Device Sequence Number: 10612390
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: (01)08714729999881(17)260730(10)34812557
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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: 07/30/2026
• Device Model Number: M00519351
• Device Catalogue Number: M00519351
• Device Lot Number: 0034812557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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