MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM GASTROSCOPE MODEL EG-760R; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EG-760R

Device Problem Partial Blockage (1065)

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

Event Type  malfunction  

Event Description

On (b)(6) 2024, fujifilm corporation was informed of an event involving eg-760r.It was reported that during a diagnostic procedure, the co2-would not insufflate.There was an 8-minutes delay to switch scopes.There was no harm or injury to the patient.No additional information was provided.

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 obtained information of this event, the repair of the subject endoscope had completed, and no further investigation was possible.The local service center explained that it could have been a piece of disposable cleaning brush debris may have clogged the nozzle.But fujifilm could not identify what it was.[consideration of health hazards] it is not known at what point in the endoscopy process the foreign object that was clogging the air/water nozzle was present in the air/water channel.The possibility that the foreign object existed during/before the reprocessing process prior to the endoscopy cannot be ruled out.Therefore, there is a possibility of cross-infection due to inadequate reprocessing.[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 GASTROSCOPE MODEL EG-760R
• Type of Device: GASTROSCOPE 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: 18637448
• MDR Text Key: 335431366
• Report Number: 3001722928-2024-00004
• Device Sequence Number: 1
• Product Code: FDS
• 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
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-760R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2022
• 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