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

Model Number	EC-760R-V/L
Medical Device Problem Codes	Blocked Connection (2888); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-600HL
• Common Device Name: 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
• Report Number: 1000513161-2024-00001
• Device Sequence Number: 8173712
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)210801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown