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

Model Number	M00519351
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	06/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the rectum 6cm from the anus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2024.During the procedure, the tip of the knife did not respond.After being removed from the endoscope, it was found that the clotting disc of the knife tip was detached and only the electrode shaft was left.Another orise proknife was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6) hospital.Block h6: imdrf device code a0501 captures the reportable event of electrode detachment.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is the first affiliated hospital of chongqing medical university.Block h6: imdrf device code a0501 captures the reportable event of electrode detachment.Block h11: the returned orise proknife was analyzed, and a product analysis observed the electrode was damaged and detached.It was observed in the picture and video provided that the device was in the patient's anatomy with the attached electrode.The reported event that the electrode was detached was confirmed.Based on all available information, it is likely that procedural factors such as the length of time used, power settings, handling technique, and tissue composition resulted in electrode damage.Subsequent use of the electrode resulted in the detachment.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the rectum 6cm from the anus during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2024.During the procedure, the tip of the knife did not respond.After being removed from the endoscope, it was found that the clotting disc of the knife tip was detached and only the electrode shaft was left.Another orise proknife was used to complete the procedure.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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19626105
• Report Number: 3005099803-2024-03071
• Device Sequence Number: 6433957
• Product Code: KNS
• UDI-Device Identifier: 08714729999881
• UDI-Public: 08714729999881
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 03/15/2025
• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Device Lot Number: 0031519091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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