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	09/20/2023
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 (esd) procedure performed on (b)(6) 2023.During the procedure, the electrode detached.It was unknown if the electrode detached inside the patient; however, the physician expects the tip to pass naturally through the patient if it did.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of the electrode detachment.Block e1: initial reporter facility name: (b)(6) hospital.City: (b)(6).
Additional Manufacturer Narrative
Block e1: initial reporter facility name: medical (b)(6) hospital.Block h2: correction e1: initial reporter phone and fax numbers have been corrected.Imdrf device code a0501 captures the reportable event of the electrode detachment.Block h10: investigation results the returned orise proknife device was analyzed, and visual evaluation noted that the electrode was not visible.However, it was found that the electrode tip was detached from the device during microscopic evaluation.No other issues were noted.The reported event was confirmed.Based on all available information, it is possible that the electrode detachment was caused by the manipulation, patient's anatomy, or technique used during the procedure.The evidence suggests that the electrode tip broke due to excessive force applied.Therefore, the most probable root cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2023.During the procedure, the electrode detached.It was unknown if the electrode detached inside the patient; however, the physician expects the tip to pass naturally through the patient if it did.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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17966217
• Report Number: 3005099803-2023-05507
• Device Sequence Number: 7669939
• 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): 11/17/2023

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: 03/30/2025
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 0032370208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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