MAUDE Adverse Event Report: FUJIFILM CORPORATION FUJIFILM DUODENOSCOPE MODEL ED-580XT; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number ED-580XT

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Perforation of Esophagus (2399)

Event Date 08/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, fujifilm healthcare americas corporation was informed of an event involving ed-580xt.It was reported that the patient had a tear/performation after attempting to pass scope through the esophagus.The doctor noted that he is accustomed to using the olympus scopes.Recently during the procedure, he perforated the esophagus ((through and through).He indicated there was resistance before the scope was pushed further and he immediately used a egd scope to inspect.The patient required additional procedure and placement of stent.Patient remained stable throughout rest of hospital stay and has been discharged to skilled nursing facility.

• Brand Name: FUJIFILM DUODENOSCOPE MODEL ED-580XT
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): FUJIFILM CORPORATION; 798 miyanodai kaisei-machi; ashigarakami-gun,, kanagawa 258-8 538; JA 258-8538
• MDR Report Key: 17666899
• MDR Text Key: 322468126
• Report Number: 1000513161-2023-00053
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 14547410359289
• UDI-Public: (01)14547410359289
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ED-580XT
• Device Catalogue Number: N/A
• Device Lot Number: 1D127G073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/02/2023
• Device Age: 3 YR
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female