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

Model Number TJF-Q190V

Device Problem Contamination (1120)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 07/21/2024

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 353121185
• Report Number: 2429304-2024-0000418
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2024,10/01/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White