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

Model Number M00519361

Device Problems Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964)

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

Event Date 09/24/2021

Event Type  malfunction  

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).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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that an orise proknife was used in the colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the knife became unable to add local injection, so cleaning and flushing of the device was performed.However, the problem persisted and did not improve.The device continued to be used in the procedure and the electrode tip detached.The tip was not removed and was left inside the patient to pass naturally.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0501 captures the reportable event of electrode detachment.Block h10: investigation results: the returned acquire eus fnb needle was analyzed, and a visual evaluation noted that a kink was observed along the length of the catheter.The electrode tip was still present and intact.A functional evaluation noted that the electrode did not extend out through the tip.Additionally, fluid did not pass through the catheter when injected into the injection port.The syringe experienced resistance to the injection immediately.Based on all available information and the condition of the returned device, 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.Additionally, it is likely that the anatomy location, the colon, contributed to the challenges encountered.The investigation concluded the most probable cause is unintended use error caused or contributed to event, stating the interaction between the user and device, or sample, caused or contributed to the error.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 colon during an endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, the knife became unable to add local injection, so cleaning and flushing of the device was performed.However, the problem persisted and did not improve.The device continued to be used in the procedure and the electrode tip detached.The tip was not removed and was left inside the patient to pass naturally.The procedure was completed with another orise proknife.There were no patient complications reported as a result of this event.

• 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: 12683197
• MDR Text Key: 278653429
• Report Number: 3005099803-2021-05379
• 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,Followup
• Report Date: 01/07/2022

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
• Device Operator: Health Professional
• Device Model Number: M00519361
• Device Catalogue Number: 1936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/07/2022
• 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