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 12/09/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an orise proknife was used during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021. During the procedure, the electrode did not move at all and it may have become disconnected. 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.

Manufacturer Narrative

Initial reporter address 1: (b)(6). Medical device problem code: (b)(4). Investigation results the returned orise proknife was analyzed, a visual evaluation was performed and the electrode was not present at the tip of the device. 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 damage. Subsequent use of the electrode may have resulted in the detachment. The investigation concluded that the most probable root cause is adverse event related to procedure, which indicates that the event occurred due to the nature of the procedure, and the device had no influence on the event. 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.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13625114
• MDR Text Key: 288106279
• Report Number: 3005099803-2022-00672
• 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: Other,Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: M00519351
• Device Catalogue Number: 1935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• 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