MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE

Model Number	TJF-Q190V
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	Encephalopathy (1833); Sepsis (2067); Drug Resistant Bacterial Infection (4553)
Date of Event	05/07/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that there were four (4) potential patients directly impacted by one suspected medical device.The patients underwent procedures involving the same individual suspected medical device between (b)(6) 2024.The patient referenced in this report was admitted to the hospital on (b)(6) 2024 for an endoscopic retrograde cholangiopancreatography (ercp) procedure with suspected medical device for removal of a stent previously placed in (b)(6) 2023.This patient had a past medical history of untreated stage iv lung cancer, pancreatic adenocarcinoma, and gero and was on palliative cares at an assisted living facility for multiple malignancies.The procedure was unable to replace stents after 2 hours of attempts to advance the duodenoscope.The patient was discharged the same day.The patient had an informational visit with hospice on (b)(6) 2024 with plans to transition to home hospice.The patient was then admitted on (b)(6) 2024 for worsening abdominal pain and underwent lnterventional radiology (ir) cholangiography and permanent stenting of a malignant stricture of the common bile duct on (b)(6) 2024.The patient had improving abdominal pain and was discharged on (b)(6) 2024.On (b)(6) 2024, the patient was admitted for acute metabolic encephalopathy and septic shock.The patient had been set to admit to hospice at an assisted living facility on (b)(6) 2024, but plans changed due to her returning to the hospital.Blood culture on admission was positive for carbapenamase-producing carbapenem resistant e.Coli (cp-cre) and klebsiella pneumoniae.The family approved no escalation of cares beyond intravenous antibiotics and fluids.The patient passed away on (b)(6) 2024.On (b)(6) 2024, ercp procedure involving suspected medical device was identified as possible link between multiple cp-cre infections.On august 21, 2024, suspected medical device was examined by borescope during facility investigation.Borescope revealed a small tear within the inner sheath of the device.It is unknown when the tear appeared on the scope, what caused it, and whether it was present for ercp procedures involving affected patients.The customer further reported that the death was potentially caused by this subject device; however, the customer was not sure if this device was the main cause of the death.The device had an inner sheath tear which the customer was not aware of, and they used the scope on several patients.The customer further stated that the device might have caused a cross contamination between patients.Reportedly, the device has been in quarantine in a secure location.The customer confirmed that the device passed the leak test prior to procedures being done.This report is related to the following linked patient identifiers: patient 1 (b)(6), patient 2 (b)(6), patient 3 (b)(6), patient 4 (b)(6).

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 20345297
• Report Number: 2429304-2024-0000420
• Device Sequence Number: 7994711
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/01/2024
• Report Date (Section F): 09/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2024
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/01/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLIANCE II 60ML SYRINGE/GUAGE ASSEMBLY; CRE FIXED WIRE ESOPHAGEAL BALLOON DILATION GATH 6F; CRE PRO WG 18-19-20MM X 240CM; HYDRA JAGWIRE ST 260 STRAIGHT TIP 0.032IN; RESCUE RAT TOOTH/ALLIGATOR GRASP FORCEP 8X230MM; RX ACCESSORY RAPID REFILL CONT LNJ SYSTEM; SENSATION SHORT THROW SNARE MED OVAL FLEXIBLE 27MM
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White