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

Model Number M00519351

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation results: the returned orise proknife was analyzed, a visual evaluation was performed and the electrode was detached from the device and not returned.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 handling and tissue composition, resulted in an electrode detachment.The ifu warns the user to discontinue use if damage is noted.Use of the electrode while damaged can result in the subsequent detachment of the electrode.The investigation concluded the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an orise proknife was used in the rectum during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the handle was actuated, but the tip did not extend.The procedure was completed with a different 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 the investigation results which revealed that electrode was detached from the device.

• Brand Name: ORISE PROKNIFE
• Type of Device: 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: 12502219
• MDR Text Key: 272487972
• Report Number: 3005099803-2021-04602
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K200404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Device Lot Number: 27159203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1