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

Model Number	M00519361
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the ascending colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the orise proknife electrode "broke off" outside of the patient, when it was being cleaned with wet gauze.The user was able to successfully complete the esd procedure without an additional cutting device.There were no patient complications reported as a result of this event.Note: it was reported that the erbe vio 300 generator was being used with spray coag setting at 90 watts, which would increase the voltage past the maximum recommended settings; the instructions for use (ifu) document states: "precaution: the recommended maximum settings on the generator are the following: 2900 vp (5800 vp-p).Increasing the voltage past the maximum recommended generator settings may compromise the electrode.".
Additional Manufacturer Narrative
Block h6: medical device problem code a0501 captures the reportable event of electrode detachment of device or device component.Block h10: investigation results the returned orise proknife was analyzed, a visual evaluation was performed and confirmed that the electrode broke off.The broken electrode was not returned for analysis.No other issues were noted.Based on all available information and the condition of the returned device, it is most likely that a sideways force was applied to the electrode when it was extended during the cleaning process.This could have affected the device's performance and it's integrity leading to the electrode detachment.The investigation concluded the most probable cause is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the ascending colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6), 2021.During the procedure, the orise proknife electrode "broke off" outside of the patient, when it was being cleaned with wet gauze.The user was able to successfully complete the esd procedure without an additional cutting device.There were no patient complications reported as a result of this event.Note: it was reported that the erbe vio 300 generator was being used with spray coag setting at 90 watts, which would increase the voltage past the maximum recommended settings; the instructions for use (ifu) document states: "precaution: the recommended maximum settings on the generator are the following: 2900 vp (5800 vp-p).Increasing the voltage past the maximum recommended generator settings may compromise the electrode.".

• 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
• MDR Report Key: 11547493
• Report Number: 3005099803-2021-01235
• Device Sequence Number: 3815033
• Product Code: KNS
• UDI-Device Identifier: 08714729999898
• UDI-Public: 08714729999898
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021

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: 09/25/2022
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 0026658205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1