MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM VIDEO ENDOSCOPE 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  

Manufacturer Narrative

[inspection of the actual device] fujifilm inspected the subject endoscope at the local service center.A white foreign substance was stuck in the water jet nozzle at the distal end of the endoscope, and the "double water stream" pointed out by the facility could be reproduced.[consideration of health hazards] it is unknown at what point in the endoscopy process the white foreign substance that was clogging the water jet nozzle was present in the channel of the endoscope.The possibility that it existed during or before the reprocessing process prior to the subject procedure cannot be denied.Therefore, the possibility of cross-infection due to inadequate reprocessing cannot be ruled out.The facility also indicated that the water supplying caused non-serious injury to the patient's gastrointestinal wall.Depending on the setting of the water supply device and the patient's condition (e.G., if the digestive tract wall is more fragile than usual), water delivered through the water jet nozzle may cause minor damage or bleeding.In this subject procedure, it is also possible that a foreign substance clogged the water jet nozzle and narrowed the water jet outlet, causing a flow of water with higher-than-normal water pressure to flow out.In any case, however, there is no risk of perforation or other serious injury resulting from the water flow from the water jet nozzle.[consideration of the cause] it was difficult to determine at what point in the endoscopy process the white foreign object that was clogging the water jet nozzle was present in the channel of the subject endoscope, and the cause could not be identified.

Event Description

On (b)(6) 2023 fujifilm corporation was informed of an event involving ec-760r-v/l.It was reported that the scope is spraying a double water stream out of the distal tip, there is difficulty putting the first step through the water channel and the blue water indicator ring around the water button needs to be replaced.The patient received minor micro tearing of the mucosa.No intervention or treatment was needed.There was no procedure delay.

• Brand Name: FUJIFILM VIDEO ENDOSCOPE 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: 18585952
• MDR Text Key: 334729865
• Report Number: 3001722928-2024-00002
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 14547410358688
• UDI-Public: (01)14547410358688(11)201101
• 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
• 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: 12/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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