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

Model Number	M00519361
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	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device problem code: (b)(4).Investigation results the returned orise proknife was analyzed, and a visual analysis found no problems with the handle, however a kink was observed in the working length.Additionally, the tip of the electrode was observed to be detached.The ceramic tip was removed from the device to observe the location of detached electrode.A functional evaluation noted that no resistance was felt when actuating the thumb slide on the handle, however the electrode did not extend from the tip.No other issues were noted.Based on all available information and the condition of the returned device, it is likely that procedural factors, such as the length of time used, power settings required, handling technique, and/or tissue composition resulted in the electrode detachment.The investigation concluded the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a 2 mm orise proknife electrode was used during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.During the procedure, the electrode does not move at all.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the electrode was detached.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13690727
• Report Number: 3005099803-2022-01006
• Device Sequence Number: 1906315
• 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
• Report Date (Section B): 03/07/2022

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 Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 27799549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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