MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE EC-600WL; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EC-600WL

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 06/30/2023

Event Type  Injury  

Event Description

On june 30, 2023, fujifilm healthcare americas corporation was informed of an event involving ec-600wl.This report addresses the first of four events that occurred at the user facility.It was reported that during a procedure the patient experienced a minor abrasion in the cecum while using the water jet function on the scope.The procedure was completed successfully without required intervention.There is no death associated with the event.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE EC-600WL
• Type of Device: COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 17409961
• MDR Text Key: 319957501
• Report Number: 1000513161-2023-00048
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EC-600WL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other