BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORISE PROKNIFE

    MDR report key: 23539426 · Received November 13, 2025

    Report

    Report Number
    3005099803-2025-05769
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    March 1, 2022
    Report Date
    November 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K200404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 MARCH 1, 2022, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN MARCH 2022 AND DECEMBER 2023. BLOCK D4, H4: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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: DENNIS YANG; MOHAMMAD K. HASAN; YASI XIAO; MOAMEN GABR; SALAMAAN JAWAID; MAI A. KHALAF; NEIL S. SHARMA; MARIA JOSE ROJAS DE LEON; MOHAMED O. OTHMAN; PETER V. DRAGANOV. "THE USE OF A SELF-ASSEMBLING PEPTIDE GEL FOR STRICTURE PREVENTION IN THE ESOPHAGUS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION: A U.S. MULTICENTER PROSPECTIVE STUDY (WITH VIDEO)" CENTER FOR INTERVENTIONAL ENDOSCOPY, ADVENTHEALTH, ORLANDO, FLORIDA, USA, AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY 0016-5107/$36.00, HTTPS://DOI.ORG/10.1016/J.GIE.2024.03.012. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF A HEMORRHAGE/BLOOD LOSS/BLEEDING. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ORISE PROKNIFE THROUGH THE ARTICLE "THE USE OF A SELF-ASSEMBLING PEPTIDE GEL FOR STRICTURE PREVENTION IN THE ESOPHAGUS AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION: A U.S. MULTICENTER PROSPECTIVE STUDY (WITH VIDEO)" BY YANG ET AL. PER THE ARTICLE, BETWEEN MARCH 2022 AND DECEMBER 2023, 43 PATIENTS SUFFERING FROM SUPERFICIAL SQUAMOUS CELL ESOPHAGEAL CARCINOMA UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING AN ORISE PROKNIFE. AFTER ESD, SELF-ASSEMBLING PEPTIDE (SAP) WAS APPLIED OVER THE RESECTION SITE. THREE PATIENTS EXPERIENCED POST-OPERATIVE BLEEDING, 1 PATIENT WAS ENDOSCOPICALLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175935 ORISE PROKNIFE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention