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

Model Number	M00519351
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: the patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0501 captures the reportable investigation results of electrode detached.Block h11: investigation results: the returned orise proknife was received for analysis.Visual examination revealed that the device returned without the electrode.The reported event of difficult to extend and retract was not confirmed; however, the device returned without the electrode.Based on the available information, the investigation findings cannot be established due to the device returning without the electrode.No issues were found that could have been related to the reported issue during manufacturing documentation review.The electrode was not returned for analysis to identify any defect with the device.Additionally, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the fundus of stomach during an endoscopic submucosal dissection (esd) procedure on (b)(6) 2024.During the procedure, the proknife could not be extended or retracted.The procedure was completed using another orise proknife.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation results; the device returned without the electrode.Please see block h11 for full investigation details.

• 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: 20480683
• Report Number: 3005099803-2024-05100
• Device Sequence Number: 20899617
• 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
• Report Date (Section B): 10/18/2024

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: 04/24/2025
• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Device Lot Number: 0031677318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2023
• 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