BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROKNIFE XL

    MDR report key: 23652784 · Received November 25, 2025

    Report

    Report Number
    3005099803-2025-06487
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    April 1, 2019
    Report Date
    November 25, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF APRIL 1, 2019, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN APRIL 1, 2019, AND MAY 31, 2023. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WERE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE: NENGPING LI; YANG QI; QIANYI LI; WENFEI YAO; YUQUAN WU. "PRECUT OVER A PANCREATIC DUCT STENT VERSUS TRANSPANCREATIC PRECUT SPHINCTEROTOMY FOR DIFFICULT BILIARY CANNULATION IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A RETROSPECTIVE COHORT STUDY" DEPARTMENT OF GENERAL SURGERY, RUIJIN HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE, SHANGHAI 200025, CHINA, DIGESTIVE DISEASES AND SCIENCES (2024) 69:3962-3969, HTTPS://DOI.ORG/10.1007/S10620-024-08603-6. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF IMAGING REQUIRED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A NEEDLE KNIFE THROUGH THE ARTICLE TITLED, "PRECUT OVER A PANCREATIC DUCT STENT VERSUS TRANSPANCREATIC PRECUT SPHINCTEROTOMY FOR DIFFICULT BILIARY CANNULATION IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A RETROSPECTIVE COHORT STUDY", BY NENGPING LI ET. AL. PER THE ARTICLE, BETWEEN (B)(6) 2019, AND (B)(6), 2023, A STUDY OF 967 PATIENTS SUFFERING FROM PANCREATICOBILIARY DISEASE UNDERWENT ERCP. TWO METHODS WERE USED: PANCREATIC DUCT STENT (PPDS) AND TRANSPANCREATIC PRECUT SPHINCTEROTOMY (TPS) TO PROMOTE BILIARY ACCESS: THE FOLLOWING OCCURRED WITH THE STUDY PATIENTS: POST-ERCP PANCREATITIS AND WERE MANAGED CONSERVATIVELY. ONE PATIENT EXPERIENCED MODERATE SEVERITY OF PEP, A CT-SCAN WAS PERFORMED AND REVEALED PERIPANCREATIC FLUID COLLECTION. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029929 MICROKNIFE XL UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention