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

Model Number	M00532810
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl sphincterotome was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the needle fell out of the device and into the patient after minimally touching the mucosa.The procedure was completed with another microknife xl.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a microknife xl sphincterotome was used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, the needle fell out of the device and into the patient after minimally touching the mucosa.The procedure was completed with another microknife xl.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h2 (correction): block b2 has been corrected.Block h6: imdrf device code a0401 captures the reportable event of cutting wire break.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.

• Brand Name: MICROKNIFE XL
• Common Device Name: 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21734135
• Report Number: 3005099803-2025-01341
• Device Sequence Number: 18340457
• Product Code: KNS
• UDI-Device Identifier: 08714729172017
• UDI-Public: (01)08714729172017(17)260404(10)33762612
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K973826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2026
• Device Model Number: M00532810
• Device Catalogue Number: M00532810
• Device Lot Number: 0033762612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 04/22/2025
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown