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 Code	Drug Resistant Bacterial Infection (4553)
Date of Event	07/21/2024
Type of Reportable Event	Serious Injury
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 cholecystitis and septic shock.The patient's blood cultures were positive for pan sensitive e.Coli on admission.The patient underwent an endoscopic retrograde cholangiopancreatography (ercp) procedure with suspected medical device to remove stones on (b)(6) 2024.The patient's gallbladder drain was cultured on (b)(6) 2024 and was positive for carbapenem resistant e.Coli (cp-cre).The cp-cre was not treated since the patient was improving on current regimen.The patient was discharged on home health 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 (b)(6) 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 reiterated that 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: 20345557
• Report Number: 2429304-2024-0000418
• Device Sequence Number: 18863299
• 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: EXTRACTOR PRO RX 7-6F 15-18MM 200CM; HYDRATOME RX 4.4F 20MM W/ 260CM GW; RX ACCESSORY RAPID REFILL CONT LNJ SYSTEM; SPYSCOPE DS II DIGITAL ACCESS & DELIVERYCATH 4661; SYPGLASS RETRIEVAL BASKET 286CM X 15MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White