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

Model Number	M00519390
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 esophagus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, after some usage, the electrode was noticeably bent inside the patient.The physician removed the orise proknife from the endoscope and patient.The user tried to manually bend the electrode to straighten it, however the electrode broke and detached.The procedure was completed with a non-bsc resection knife.There were no patient complications reported as a result of this event.Note: it was reported that an erbe vio 3 generator was used for this procedure.However, according to the instructions for use (ifu), "the orise proknife is only for use with erbe vio 200d/300d generators".Additionally, the information provided indicates that the cleaning tool was used incorrectly; the electrode was "being jammed into the cleaning tool very aggressively with it extended." according to the ifu document: "cleaning tool to be used with the orise proknife removed from the scope and electrode retracted".However, it was noted that the electrode was extended when the cleaning tool was used.

• 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: 11547483
• Report Number: 3005099803-2021-01234
• Device Sequence Number: 17097562
• Product Code: KNS
• UDI-Device Identifier: 08714729995593
• UDI-Public: 08714729995593
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 03/22/2021

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: 11/02/2022
• Device Model Number: M00519390
• Device Catalogue Number: 1939
• Device Lot Number: 0026679577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1