Fujifilm Diathermic Slitter (FlushKnife) DK2618J -B20-Recalls & reported problems
Fujifilm Corporation · These instruments have been designed to be used with specified endoscopes to cut tissue using high-frequency current within the digestive tract. Both the ball tip type and the needle type instruments are indicated for ablation, incision, dissection, avulsion, cauterization, coagulation and hemostasis of tissue within the digestive tract. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547410334500), received between May 17, 2021 and Sep 9, 2021 — classified as 1 injury, 1 malfunction.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Perforation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON MAY 12, 2021 FUJIFILM MEDICAL SYSTEMS U.S.A. 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. DURING AN INTERNAL REVIEW, IT WAS IDENTIFIED THAT THIS EVENT WAS NOT REPORTED TO FDA BY THE IMPORTER AS REQUIRED BY 21 CFR 803. THIS EVENT WAS REPORTED TO THE MANUFACTURER ON 04/23/2021. THE MANUFACTURER REPORTED THIS EVENT TO FDA UNDER REPORT # 3001722928-2021-00009.
Patient problems: Perforation
MAUDE report 12445974 ↗MalfunctionMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 .
Patient problems: Perforation
MAUDE report 11831197 ↗
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- Single Use Electrosurgical Hemostatic Forceps FD-411UROlympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC15 reports
- SUCTION VALVE MAJ-207Olympus Medical Systems Corp. · FORCEPS, BIOPSY, ELECTRIC13 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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