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

Model Number	M00519361
Medical Device Problem Codes	Mechanical Problem (1384); Retraction Problem (1536); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation result code c070603 captures the investigation analysis of the tip was damaged and had broken off from the device.Investigation results the returned orise proknife was analyzed, and a visual evaluation found that the tip was damaged and had broken off from the device.In addition, a kink on the working length of the catheter was observed and procedural residue was noticed on the distal tip.No other problems were noted.Product analysis identified that the tip was damaged and had broken off from the device.It was reported that the insertion and removal of the electrode tip did not go smoothly during use.Extensive use of the device and other procedural factors, such as power settings for the electrode, handling, and/or tortuous anatomy, may have resulted in electrode tip damage.Therefore, based on all available information and analysis of the returned device, the most probable cause is adverse event related to procedure.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 was used in the rectum during an endoscopic submucosal dissection (esd) procedure performed on (b)(6)2022.During the procedure, the insertion and removal of the electrode tip did not go smoothly.The procedure was completed with a non bsc device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of electrode detachment.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16471768
• Report Number: 3005099803-2023-00860
• Device Sequence Number: 20149510
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: 07/07/2024
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 0030115401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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