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	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the orise proknife electrode separated outside of the patient.The procedure was completed with another orise proknife.There were no patient complications 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 expiration and device manufacture dates are unknown.Block e1: (b)(6).Block h6: imdrf device code a0501 captures the reportable event of electrode detachment.
Additional Manufacturer Narrative
Block e1: initial reporter city (b)(6).Block h6: imdrf device code a0501 captures the reportable event of electrode detachment.Block h2: block d4 was updated with the correct lot number.Block e1 initial reporter first name was updated.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the orise proknife electrode separated outside of the patient.The procedure was completed with another orise proknife.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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18495264
• Report Number: 3005099803-2024-00012
• Device Sequence Number: 3533727
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2024

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: 08/17/2025
• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Device Lot Number: 0032747874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2023
• 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