BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORISE PROKNIFE

    MDR report key: 23539429 · Received November 13, 2025

    Report

    Report Number
    3005099803-2025-05754
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    December 1, 2020
    Report Date
    March 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K200404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (B)(6) 2020, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN DECEMBER 2020 AND NOVEMBER 2022. 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 E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL, (B)(6) MEDICAL SCHOOL; REPORTED HERE AS THE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: HIROYUKI AIHARA; MOHAMED O. OTHMAN; SALMAAN A. JAWAID; NEIL R. SHARMA; EMRE GORGUN; UZMA D. SIDDIQUI; JOYCE A. PEETERMANS; MATTHEW J. ROUSSEAUI; MAKOTO NISHIMURA. "A MULTICENTER, RETROSPECTIVE STUDY OF A THROUGH-THE-NEEDLE INJECTION-CAPABLE ELECTROSURGICAL KNIFE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION" DIVISION OF GASTROENTEROLOGY, HEPATOLOGY AND ENDOSCOPY, BRIGHAM AND WOMEN'S HOSPITAL, HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA, AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY 0016-5107/$36.00, HTTPS://DOI.ORG/10.1016/J.GIE.2024.06.011. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF A PERFORATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Additional Manufacturer Narrative · 0

    BLOCK B3: THE EXACT DATE OF THE EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE OF DECEMBER 1, 2020, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN DECEMBER 2020 AND NOVEMBER 2022. 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 E1: INITIAL REPORTER FACILITY NAME: BRIGHAM AND WOMEN'S HOSPITAL, HARVARD MEDICAL SCHOOL; REPORTED HERE AS THE FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: HIROYUKI AIHARA; MOHAMED O. OTHMAN; SALMAAN A. JAWAID; NEIL R. SHARMA; EMRE GORGUN; UZMA D. SIDDIQUI; JOYCE A. PEETERMANS; MATTHEW J. ROUSSEAUI; MAKOTO NISHIMURA. "A MULTICENTER, RETROSPECTIVE STUDY OF A THROUGH-THE-NEEDLE INJECTION-CAPABLE ELECTROSURGICAL KNIFE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION" DIVISION OF GASTROENTEROLOGY, HEPATOLOGY AND ENDOSCOPY, BRIGHAM AND WOMEN'S HOSPITAL, HARVARD MEDICAL SCHOOL, BOSTON, MASSACHUSETTS, USA, AMERICAN SOCIETY FOR GASTROINTESTINAL ENDOSCOPY 0016-5107/$36.00, HTTPS://DOI.ORG/10.1016/J.GIE.2024.06.011. BLOCK H6: IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF A PERFORATION. IMDRF IMPACT CODE F2303 CAPTURES THE REPORTABLE EVENT OF MEDICATION REQUIRED. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED. BLOCK H11: CORRECTION BLOCK H6 PATIENT CODES CORRECTED BASED ON THE MEDICAL REVIEW OF THE COMPLAINT RECORD ON FEBRUARY 13, 2026.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ORISE PROKNIFE THROUGH THE ARTICLE "A MULTICENTER, RETROSPECTIVE STUDY OF A THROUGH-THE-NEEDLE INJECTION-CAPABLE ELECTROSURGICAL KNIFE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION" BY AIHARA ET AL. PER THE ARTICLE, BETWEEN DECEMBER 2020 AND NOVEMBER 2022, 579 PATIENTS SUFFERING FROM CANCEROUS LESIONS UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING AN ORISE PROKNIFE. AMONG THE PROCEDURES, 15 PATIENTS EXPERIENCED ADVERSE EVENTS; 11 PATIENTS EXPERIENCED DELAYED BLEEDING WITH NO BLOOD TRANSFUSION REQUIRED, 3 PATIENTS EXPERIENCED PERFORATION, ONE PATIENT EXPERIENCED RECTAL PERFORATION AND WAS TREATED WITH CLIPS ENDOSCOPICALLY, A SECOND PATIENT EXPERIENCED PERFORATION FROM THE ASCENDING COLON, STILL WAS TREATED WITH CLIPS AND ANTIBIOTICS FOR 3 DAYS AND A THIRD PATIENT WITH CECAL PERFORATION MANAGED WITH MULTIPLE CLIPPINGS AND IV ANTIBIOTICS. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING ORISE PROKNIFE THROUGH THE ARTICLE "A MULTICENTER, RETROSPECTIVE STUDY OF A THROUGH-THE-NEEDLE INJECTION-CAPABLE ELECTROSURGICAL KNIFE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION" BY AIHARA ET AL. PER THE ARTICLE, BETWEEN (B)(6) 2020 AND (B)(6) 2022, 579 PATIENTS SUFFERING FROM CANCEROUS LESIONS UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING AN ORISE PROKNIFE. AMONG THE PROCEDURES, 15 PATIENTS EXPERIENCED ADVERSE EVENTS; 11 PATIENTS EXPERIENCED DELAYED BLEEDING WITH NO BLOOD TRANSFUSION REQUIRED, 3 PATIENTS EXPERIENCED PERFORATION, ONE PATIENT EXPERIENCED RECTAL PERFORATION AND WAS TREATED WITH CLIPS ENDOSCOPICALLY, A SECOND PATIENT EXPERIENCED PERFORATION FROM THE ASCENDING COLON, STILL WAS TREATED WITH CLIPS AND ANTIBIOTICS FOR 3 DAYS AND A THIRD PATIENT WITH CECAL PERFORATION MANAGED WITH MULTIPLE CLIPPINGS AND IV ANTIBIOTICS. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175938 ORISE PROKNIFE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention