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

Model Number	M00519361
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental emdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, there was a considerable time lag between the manipulation of the thumb tab on the handle and the insertion and removal of the knife.The catheter kinked during jigging and the knife could not be extended or retracted.The knife was checked by extending and retracting on the desk, but the tip of the knife came off as the knife protruded.The electrode tip detached outside of the patient.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: medical device problem code a0501 captures the reportable event of electrode detachment.Block h10: investigation results: the returned orise proknife needle was analyzed, a visual evaluation was performed and it was observed there was a kink in the middle of the catheter.In addition, it was observed that the thumb slider could not be adjusted without significant force and the probe did not retract or extend through the tip as it was confirmed the tip was missing.No other issues were noted.Based on all available information and the condition of the returned device, the conclusion that this type of damage is likely the result of force being applied when resistance is encountered during advancement of the device and/or actuation of the handle.Moreover, the reported complaint states the kink was created during retraction confirming the kink was not there out of the box and occurred during actuation.The investigation concluded the most probable cause of the analyzed failure is unintended use error caused or contributed to event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that an orise proknife was used in the stomach during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, there was a considerable time lag between the manipulation of the thumb tab on the handle and the insertion and removal of the knife.The catheter kinked during jigging and the knife could not be extended or retracted.The knife was checked by extending and retracting on the desk, but the tip of the knife came off as the knife protruded.The electrode tip detached outside of the patient.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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12456236
• Report Number: 3005099803-2021-04587
• Device Sequence Number: 19140588
• 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): 11/24/2021

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: 04/12/2023
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Device Lot Number: 0027271856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• 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