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

Model Number	M00519361
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	06/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection procedure performed on (b)(6) 2022 during the procedure, the electrode was detached.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter name and address: initial reporter information.Initial reporter address: (b)(6).Initial reporter state: (b)(6).Lot #, device manufacture date: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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.
Additional Manufacturer Narrative
Block e1: initial reporter information initial reporter facility name: (b)(6) medical center.Initial reporter address: (b)(6).Initial reporter state: (b)(6).Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0501 captures the reportable event of electrode detachment.Block h10: investigation results the returned orise proknife was analyzed, a visual evaluation was performed and the distal end of the electrode was not visible.The ceramic tip was removed, and it was observed that the distal end of the electrode had detached and was not returned.Based on all available information and the condition of the returned device, it is likely that procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition resulted in the electrode damage, and subsequent use of the electrode resulted in the detachment.It indicates that the event occurred due to the nature of the procedure, and the device had no influence on the event.The investigation concluded the most probable cause is adverse event related to procedure.A risk review was completed confirmed that the event of electrode detached was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labelling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.There were no issues found with the translation, wording, or graphics in the dfu.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection procedure performed on (b)(6) 2022.During the procedure, the electrode was detached.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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14876341
• Report Number: 3005099803-2022-03442
• Device Sequence Number: 17402180
• 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,Followup
• Report Date (Section B): 08/01/2022

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: M00519361
• Device Catalogue Number: 1936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 08/01/2022
• 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