MAUDE Adverse Event Report: FUJIFILM CORPORATION ENDOSCOPE MODEL EI-740D/S; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number EI-740D/S

Device Problem Break (1069)

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

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

Ref comp# (b)(4).

Event Description

On february 12th, 2024 fujifilm healthcare americas corporation was informed of an event involving ei-740d/s.It was reported that the up/down angulation control knob is not working due to broken metal cable.Since the cable broke, the user was not able to angulate it properly to remove it from patient.There was about 10 to 15 min delay because the user had to find a way on how to angulate the scope in order to remove it from patient.

• Brand Name: ENDOSCOPE MODEL EI-740D/S
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun; kanagawa 25885 38; JA 2588538
• MDR Report Key: 18932180
• MDR Text Key: 338079117
• Report Number: 1000513161-2024-00019
• Device Sequence Number: 1
• Product Code: FDS
• 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
• Type of Report: Initial
• Report Date: 02/23/2024,03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EI-740D/S
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1