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

Model Number	M00519351
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	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot manufacture date is unknown.Block h6: imdrf device code a0501 captures the reportable event of electrode detached.
Event or Problem Description
It was reported to boston scientific that an orise proknife was used in the colon during a colorectal endoscopic submucosal dissection (esd) procedure was performed on (b)(6) 2024.During the procedure, the electrode of the orise proknife was dislodged.It is unknown how the procedure was completed.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot manufacture date is unknown.Block h6: imdrf device code a0501 captures the reportable event of electrode detached.Block h11: the returned orise proknife was analyzed, and it was observed that the device was returned without any visible failure.After a functional and microscope inspection, it is observed that the electrode was detached.The reported event was confirmed.With all the available information, boston scientific concludes that procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition likely resulted in the electrode damage, and subsequent use of the electrode resulted in the detachment.Therefore, the most probable conclusion code is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific that an orise proknife was used in the colon during a colorectal endoscopic submucosal dissection (esd) procedure was performed on (b)(6) 2024.During the procedure, the electrode of the orise proknife was dislodged.It is unknown how the procedure was completed.No patient complications were 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: 20230610
• Report Number: 3005099803-2024-04447
• Device Sequence Number: 8667782
• 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,Followup
• Report Date (Section B): 03/03/2025

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: M00519351
• Device Catalogue Number: 1935
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 03/03/2025
• 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