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

Model Number	M00519371
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of electrode detached.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during a procedure performed on (b)(6) 2024.During the procedure, after a few applications, the tip came loose from the catheter when cleaning it outside the patient.The tip was fixed with micropore to the handle.The procedure was completed with another same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of electrode detached.Block h11: the returned orise proknife was analyzed, and product analysis observed the device was without any visible failure.Functional inspection observed the electrode was able to extend and retract completely.The electrode was not detached.Based on all available information, the most probable conclusion code is no problem detected since the device was returned without any visible failure, and after a functional inspection, the electrode was able to extend and retract completely.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during a procedure performed on (b)(6) 2024.During the procedure, after a few applications, the tip came loose from the catheter when cleaning it outside the patient.The tip was fixed with micropore to the handle.The procedure was completed with another same device.There were no patient complications reported 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20797458
• Report Number: 3005099803-2024-06017
• Device Sequence Number: 7808761
• Product Code: KNS
• UDI-Device Identifier: 08714729999904
• UDI-Public: 08714729999904
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 06/15/2025
• Device Model Number: M00519371
• Device Catalogue Number: M00519371
• Device Lot Number: 0033135814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 02/26/2025
• Date Device Manufactured: 06/16/2023
• 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