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	Serious Injury
Event or Problem Description
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.

• 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: 12445974
• Report Number: 1000513161-2021-00015
• Device Sequence Number: 3581974
• Product Code: KGE
• UDI-Device Identifier: 04547410334500
• UDI-Public: 04547410334500
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2021
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention