MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-600HL; ENDOSCOPE AND ACCESSORIES

Model Number EC-760R-V/L

Device Problems Blocked Connection (2888); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

On december 5th, 2023, fujifilm healthcare americas corporation was informed of an event involving ec-760r-v/l.It was reported that there is a clog in the distal co2 channel.Co2 is not coming out and was unable to be used during patient care.Room air was used instead.The case took longer while attempting to troubleshoot, and care deviated from the normal protocol.The patient remained safe and the procedure was completed.There was no patient harm or injury.No additional information was provided.

Manufacturer Narrative

(b)(4).

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-600HL
• Type of Device: ENDOSCOPE AND ACCESSORIES
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 18443760
• MDR Text Key: 331889124
• Report Number: 1000513161-2024-00001
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)210801
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-760R-V/L
• 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?: No
• Distributor Facility Aware Date: 12/05/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1