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 02/24/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an orise proknife was used in the ascending colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2022.About 4 hours into the procedure, the electrode was impossible to deploy.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 the electrode tip became separated from the electrode body.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).Investigation results: the returned orise proknife was analyzed, a visual evaluation was performed and no damages or additional defects were found.A functional evaluation noted that the thumb slider could easily be adjusted for electrode extension, but no electrode tip extended out.The ceramic tip was removed, and the electrode tip had become separated from the electrode body and was not returned.No other issues were noted.The reported complaint was confirmed.The electrode tip became impossible to deploy because it had become separated from the electrode body.Based on all available information and the condition of the returned device, it is most likely that heat exposure for a long period of time can promote damage in materials such as metal.The dfmea lists electrode burn (hot spot) as a potential cause for electrode assembly detachment.That being said, there are no time restrictions or warnings of the tip falling off after long periods of use.The investigation concluded the most probable root cause is adverse event related to procedure.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.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: 14174880
• MDR Text Key: 289895727
• Report Number: 3005099803-2022-02061
• 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: Physician
• Type of Report: Initial
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• 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
• Patient Sequence Number: 1