MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ENDOSCOPE MODEL EC-760R-V/L; COLONOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EC-760R-V/L

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Event Description

On (b)(6), 2023, fujifilm 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.

Manufacturer Narrative

[inspection of the actual device] fujifilm inspected the subject endoscope at the local service center, and it was confirmed that the air/water nozzle at the distal end of the endoscope was clogged.However, when fujifilm contacted our local service center, the related parts including the foreign substance clogging the air/water nozzle had been removed and disposed of, and no further investigation was possible.[consideration of health hazards] fujifilm inspected the subject endoscope at the local service center, and it was confirmed that the air/water nozzle at the distal end of the endoscope was clogged.However, when fujifilm contacted our local service center, the applicable parts had been disposed of, and no further investigation was possible.[consideration of the cause] it was difficult to determine at what point in the endoscopy process the foreign object that was clogging the air/water nozzle was present in the channel of the subject endoscope, and the cause could not be identified.

• Brand Name: FUJIFILM ENDOSCOPE MODEL EC-760R-V/L
• 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
• Manufacturer (Section G): FUJIFILM HEALTHCARE MANUFACTURING SANO OFFICE; 700 konaka-cho; sano city, tochigi 327-0 001; JA 327-0001
• Manufacturer Contact: 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8-538
• MDR Report Key: 18585951
• MDR Text Key: 334728325
• Report Number: 3001722928-2024-00003
• 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
• PMA/PMN Number: K172916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1