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	08/01/2024
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 an unknown date.It was reported that the orise electrode was dislodged.The procedure was completed using another orise proknife.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of electrode detached.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0501 captures the reportable event of electrode detached.Block h10: investigation results.The returned orise proknife was returned and analyzed.There were no visible failures and after a functional inspection, it was observed that the electrode was in good condition.Based on the available information, product analysis of the returned device did not identify any evidence of either the alleged issues or any defect on the device.Therefore, the most probable root cause is no problem detected as the device returned on good condition.
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 an unknown date.It was reported that the orise electrode was dislodged.The procedure was completed using 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 T12 Y K88; EI T12 YK88
• Manufacturer Contact: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20136686
• Report Number: 3005099803-2024-04280
• Device Sequence Number: 15319089
• 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): 10/04/2024

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: 03/04/2026
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 0034070557
• 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: 08/09/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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