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	Abdominal Pain (1685); Bacterial Infection (1735); Nausea (1970); Vomiting (2144); Bacteremia (4846)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported there were possible multiple infections of patients after use of an endoscopic retrograde cholangiopancreatography (ercp) scope, an endobronchial ultrasound (ebus) scope, and bronchoscopes that were shared between two sister facilities.At one facility it was reported a patient had a therapeutic ercp procedure done using a duodenovideoscope.Prior to the procedure, the patient experienced symptoms of nausea, vomiting, abdominal pain, abnormal liver function test, and gastric distention.After the procedure, the patient experienced pain in recovery and was kept overnight for observation then discharged the following day.The patient then presented to the emergency department (ed) two days post-procedure with bacteremia, nausea, vomiting, and abdominal pain.Two sets of blood cultures were taken from the patient which tested positive for klebsiella pneumoniae.The patient was admitted for treatment with intravenous (iv) antibiotics.Additionally, the patient underwent an esophagogastroduodenoscopy (egd) procedure to aspirate/suction out 2.5 liters of fluid to help with gastric outlet obstruction.The patient was eventually discharged to a palliative care home.The facility reported that at that time they had not cultured the endoscope or the reprocessor, but the device did pass adenosine triphosphate (atp) testing.The device was quarantined.This report is related to the following linked patient identifiers: (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: 19460907
• Report Number: 2429304-2024-0000278
• Device Sequence Number: 6443377
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/04/2024
• Report Date (Section F): 05/07/2024

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?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2024
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 80 KG