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

Model Number	M00519361
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code reportablecode captures the reportable event of detachment of device or device component.Block h6: patient code e2008 captures the reportable event of foreign body in patient.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife 2.0 mm electrode was used during an endoscopic submucosal dissection procedure.During the procedure, the needle detached and fell into the patient.The needle remains in the patient.The procedure was completed with another orise proknife.No specific information on the patient's condition.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0501 captures the reportable event of electrode detached.Block b5 was updated based on the information received.Block h11: investigation results.The returned orise proknife was received for analysis.The device was returned without any visible failure.A functional inspection was performed and revealed that the electrode was able to extend and retract completely without any issue.The reported event was not confirmed.Based on the available information, the device returned without any visible failure, and after a functional inspection, the electrode was able to extend and retract completely without any issue.Therefore, a review and analysis of all available information indicates the most probable root cause is no problem detected.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife 2.0 mm electrode was used during an endoscopic submucosal dissection procedure.During the procedure, the needle detached and fell into the patient.No attempt was made to retrieve the needle.The needle remains in the patient.The procedure was completed with another orise proknife.No specific information on the patient's condition.

• 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; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21776722
• Report Number: 3005099803-2025-01150
• Device Sequence Number: 12969148
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: (01)08714729999898
• 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,Followup
• Report Date (Section B): 05/08/2025

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 Model Number: M00519361
• Device Catalogue Number: M00519361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/13/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/08/2025
• 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: Unknown