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

Model Number M00532810

Device Problems Break (1069); Mechanical Problem (1384); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(6).(b)(4).The returned microknife xl was analyzed, and a visual evaluation noted that the cutting wire was broken at the handle section.The handle did not have any visual damage.The device was observed under magnification and the cutting wire was broken and bent at the handle section and the cut of the cutting wire was not smooth.It was also observed evidence of bending forces at the broken area.No other problems with the device were noted.The product analysis revealed that the cutting wire was broken and bent at the handle section.Based on the condition of the device and the information that the problem occurred during procedure, it is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity.The broken section of the wire was inspected under magnification and it was observed evidence of bending forces, it is most likely that the wire was bent due to handling and manipulation of the device during its use, once the wire is bent, continued attempts to actuate the handle can result in wire breakage.Based on all gathered information and the analysis performed to the returned product, it was concluded that the investigation conclusion code of this event 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.

Event Description

It was reported to boston scientific corporation that a microknife xl was used during an esophagogastroduodenoscopy (egd) and endoscopic submucosal dissection (esd) procedure performed on (b)(6) 2021.During the procedure, when the microknife xl was opened, it was noticed that the handle was damaged and the needle would not extend.It was reported that the procedure was completed; however, it is unknown what device was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be ok.This event has been deemed a reportable event based on the investigation results: the cutting wire was broken.

• Brand Name: MICROKNIFE XL
• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11882091
• MDR Text Key: 256281426
• Report Number: 3005099803-2021-02316
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: 08714729172017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973826
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: M00532810
• Device Catalogue Number: 3281
• Device Lot Number: 0025675160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1