MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DIATHERMIC SLITTER FLUSHKNIFE; ELECTRIC BIOPSY FORCEPS

Model Number	DK2618J -B20-
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: FUJIFILM DIATHERMIC SLITTER FLUSHKNIFE
• Common Device Name: ELECTRIC BIOPSY FORCEPS
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 11831197
• Report Number: 3001722928-2021-00009
• Device Sequence Number: 1085591
• Product Code: KGE
• UDI-Device Identifier: 04547410334500
• UDI-Public: 04547410334500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171096
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: DK2618J -B20-
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention