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

Model Number	M00519350
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection procedure performed on (b)(6) 2024.When the package was opened there was a kink on the device; however, the device was tested and it operated without any problems.During the procedure, the electrode was unable to deploy.The procedure was completed with another same device.There were no patient complications as a result of this event.Note: it was reported that the device was used during the procedure even though a kink was noticed on the device upon unpacking.However, the orise proknife instructions for use (ifu) states, "inspect the knife for damage.Verify that the knife has no cracks, tears, or kinks in the catheter and handle.Precaution: kinks in the catheter will hinder injection capability.Do not use the proknife if any defect is found during inspection.Please notify boston scientific and return for replacement".The physician did not follow the steps cited in the ifu.This event has been deemed a reportable event based on the investigation finding of electrode detached.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of electrode detached.Block h11: the returned orise proknife was analyzed, and the product analysis found the catheter was kinked.Functional and microscope inspection observed the device was returned without the electrode.A product labeling review identified that the device was not used per the instructions for use (ifu) / product label.It was reported that they used the device despite noticing the kink in the device.However, the instruction for use (ifu) states that "kinks in the catheter will hinder injection capability.Do not use the proknife if any defect is found during inspection".The reported event was confirmed.Based on all available information, it is likely that procedural factors such as the length of time, power settings, handling technique, and/or tissue composition resulted in the electrode damage.Subsequent use of the electrode resulted in the detachment.Therefore, the most probable root 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20182763
• Report Number: 3005099803-2024-04240
• Device Sequence Number: 15502912
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: 08714729999881
• 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): 09/10/2024

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: 02/22/2026
• Device Model Number: M00519350
• Device Catalogue Number: 1935
• Device Lot Number: 33489961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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