MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT; ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY

Model Number EG-580UT

Device Problems Residue After Decontamination (2325); Contamination /Decontamination Problem (2895)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

On june 13, 2023, fujifilm healthcare americas corporation was informed of an event involving eg-580ut.It was reported that during preparation a red liquid was observed on the balloon attached to the distal end of the scope.The scope was washed twice with aer, but the red liquid flowed out of the nozzle, and use of the scope was discontinued.There is no patient involvement, serious injury, or death associated with the event.As such, this report is being submitted in an abundance of caution.

• Brand Name: FUJIFILM ULTRASONIC ENDOSCOPE EG-580UT
• Type of Device: ENDOSCOPIC ULTRASOUND SYSTEM, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 17316100
• MDR Text Key: 319384616
• Report Number: 1000513161-2023-00032
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 14547410349068
• UDI-Public: (01)14547410349068
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-580UT
• 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?: Yes
• Distributor Facility Aware Date: 06/13/2023
• Device Age: 30 MO
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1