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

Model Number	M00519361
Medical Device Problem Codes	Failure to Cut (2587); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of electrode tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the upper digestive tract during a painless gastroscopy procedure performed on (b)(6) 2025.During the procedure, the orise proknife electrode tip could not cut and the bleeding could not be stopped.The electrode tip detached.The procedure was completed with another same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of electrode tip detachment of device or device component.Block b5 and h6 (patient code and impact code) has been updated based on the additional information received on january 4, 2026.Block h11: media inspection of the picture attached found the tip of the electrode was broken/separated.Based on this evidence the as reported code of "electrode detachment of device or device component" can be confirmed.Unable to confirm the as reported observation "device failure to cut" based on the event description, information and picture provided by the customer there is not enough evidence to determine whether the issues were induced due to the physician's technique during the procedure or were related to a device malfunction, "cause not established" is selected as the most probable causes for these events.Additionally, based on the most relevant information for the complaint including product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process, the definitive cause of the reported issues cannot be established due to lack of evidence.Additionally, without the device, it remains unknown the causes that contributed to the events.All compiled information on this investigation determines that the most probable cause is "cause not established".
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the upper digestive tract during a painless gastroscopy procedure performed on (b)(6) 2025.During the procedure, the orise proknife electrode tip could not cut and the bleeding could not be stopped.The electrode tip detached and could not be found.The procedure was completed with another same device.There were no patient complications as a result of this event.Additional information received on january 04, 2026.The bleeding was a result of cutting the tissue.The bleeding was stopped with hemostatic forceps.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of electrode tip detachment of device or device component.Block h11: the returned orise proknife was analyzed, and a product analysis found the catheter was kinked.A functional and microscope inspection observed the device was returned without the electrode.During the media inspection of the picture provided by the customer, it was possible to observe the tip of the electrode was broken/separated.With all the available information, boston scientific concludes the reported event was confirmed.Electrode broken/separated issue is likely due to procedural factors, such as the time that the device was used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage, and subsequent use of the electrode resulted in the break/separation of the component.Therefore, this code will be classified as "adverse event related to procedure".Additionally, it was found that the catheter was kinked.This failure likely has occurred due the manner as the device was handled and manipulated may have caused the reported and encountered failure.Excessive manipulation of the device without enough care could have induced the defect found.Therefore, this observed issue will be classified as "adverse event related to procedure".Regarding the reported code "device failure to cut", due to the product analysis performed on the device it was found that the electrode was broken and the catheter was kinked, because of the device condition, it is not possible to determine if the electrode could cut properly.Also, since the device cannot be functionally tested by emulating the anatomical/procedural factors encountered during the procedure, this reported issue will be classified as "unable to exclude device problem".On the other hand, the reported code of "hemorrhage, minor", will be classified as "known inherent risk of device" since the ifu states this condition as a possible adverse event.Finally, the as reported impact code of "additional device required" will be classified as "adverse event related to procedure" since the adverse event occurred due to the issues encountered during procedure.All compiled information on this investigation determines that the most probable cause is "adverse event related to procedure".A labeling review was performed, and it was confirmed that the adverse event hemorrhage, minor (immediate or delayed hemorrhages) is anticipated in the instructions for use (ifu).Also, there is no evidence the device was improperly used per the ifu, and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the upper digestive tract during a painless gastroscopy procedure performed on (b)(6) 2025.During the procedure, the orise proknife electrode tip could not cut and the bleeding could not be stopped.The electrode tip detached and could not be found.The procedure was completed with another same device.There were no patient complications as a result of this event.Additional information received on january 04, 2026.The bleeding was a result of cutting the tissue.The bleeding was stopped with hemostatic forceps.

• 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: 23881667
• Report Number: 3005099803-2025-06849
• Device Sequence Number: 11929514
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: (01)08714729999898(17)260920(10)35073196
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 04/02/2026

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 Expiration Date: 09/20/2026
• Device Model Number: M00519361
• Device Catalogue Number: M00519361
• Device Lot Number: 0035073196
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 03/05/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/19/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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 Age: 77 YR
• Patient Sex: Male
• Patient Weight: 70 KG