BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FUJIFILM DIATHERMIC SLITTER FLUSHKNIFE

    MDR report key: 11831197 · Received May 17, 2021

    Report

    Report Number
    3001722928-2021-00009
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 17, 2021
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    KGE
    UDI-DI
    04547410334500
    PMA / PMN Number
    K171096
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL LITERATURE CITATION IS AS FOLLOWS: DOHI O, YOSHIDA N, NAITO Y, ET AL. EFFICACY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION USING A SCISSORS-TYPE KNIFE WITH PROPHYLACTIC OVER-THE-SCOPE CLIP CLOSURE FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS. DIG ENDOSC. 2020;32:904-913. ALTHOUGH THE ARTICLE WAS PUBLISHED IN SEPTEMBER 2020, FUJIFILM WAS NOT MADE AWARE OF THE ADVERSE EVENTS UNTIL IT WAS REPUBLISHED IN JAPANESE IN APRIL 2021. ALTHOUGH ESD AND OTSC ARE MENTIONED IN THIS LITERATURE, THIS REPORT IS ONLY DESCRIBING ADVERSE EVENTS (INTRAOPERATIVE PERFORATION) RELATED TO ESD PROCEDURES USING THE FLUSHKNIFE. THE LITERATURE DOES NOT DESCRIBE THE DETAILED MODEL NAME, AND FUJIFILM ASSUMES DK2618J -B20- TO BE THE FLUSHKNIFE MODEL INVOLVED BASED ON THE INFORMATION PROVIDED IN THE LITERATURE. THIS PRODUCT HAS BEEN PROPERLY INSPECTED IN THE MANUFACTURING PROCESS, AND ONLY PRODUCTS THAT HAVE PASSED INSPECTION HAVE BEEN SHIPPED, AND NO REPORTS OF SIMILAR EVENTS DUE TO MANUFACTURING DEFECTS HAVE BEEN CONFIRMED FOR THIS PRODUCT SO FAR. FURTHERMORE, SINCE NO DESCRIPTION REGARDING THE MALFUNCTION OF THIS PRODUCT WAS CONFIRMED IN THE LITERATURE, IT WAS CONSIDERED THAT THE PRODUCT OPERATED NORMALLY IN RESPONSE TO THE OPERATION. THE EVENT (PERFORATION) REPORTED IN THE LITERATURE IS A KNOWN EVENT, AND NO INFORMATION INCLUDING A NEW ADVERSE EVENT WAS CONFIRMED IN THE LITERATURE. IN THE INSTRUCTION MANUAL OF THIS PRODUCT, NECESSARY WARNINGS/CAUTIONS RELATED TO PERFORATION HAVE BEEN DESCRIBED: DO NOT PUSH OUT THE SLITTER FROM THE DISTAL END OF THE TUBE QUICKLY. DO NOT ANGULATE THE ENDOSCOPE QUICKLY WHILE THE DISTAL END OF THE TUBE AND SLITTER ARE OUT. AFTER CHECKING THAT NO TISSUE IS ADHERED TO THE TIP OF THE SLITTER, SLOWLY RETURN THE TIP INSIDE THE TUBE. OTHERWISE, THE DISTAL PORTION OF THE SLITTER MAY CAUSE PERFORATION OR DAMAGE TO TISSUE. SET THE OUTPUT OF THE ELECTROSURGICAL UNIT TO THE MINIMUM WITHIN THE REQUIRED RANGE, ACCORDING TO THE INTENDED USE. DO NOT ENERGIZE LONGER THAN NECESSARY. IF SATISFACTORY RESULTS ARE NOT OBTAINED, CHECK THE CONNECTIONS OF THE CORDS, ATTACHMENT OF THE P-PLATE AND SETTINGS OF THE ELECTROSURGICAL UNIT, WITHOUT INCREASING THE OUTPUT OF THE POWER SUPPLY. SETTING THE OUTPUT HIGHER THAN NECESSARY MAY CAUSE PERFORATION OR BURNS. IF ANY ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON APRIL 23, 2021 FUJIFILM CORPORATION BECAME AWARE OF A LITERATURE STUDY WHICH AIMED TO ASSESS THE SAFETY AND FEASIBILITY OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) USING A FLUSHKNIFE FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELILIAL TUMORS (SNADETS). 37 LESIONS WERE RESECTED USING THE FLUSHKNIFE, WITH FIVE CASES OF INTRAOPERATIVE PERFORATION .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732538 FUJIFILM DIATHERMIC SLITTER FLUSHKNIFE ELECTRIC BIOPSY FORCEPS KGE FUJIFILM CORPORATION DK2618J -B20- N/A 04547410334500

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention