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  

Manufacturer Narrative

An endoscopic support specialist provided a reprocessing in-service at the user facility, which included all cleaning, leak testing, high level disinfection, delayed reprocessing and storage using information contained in the olympus reprocessing manual.The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report has been submitted by the importer under this mdr report number 2429304-2024-0000418.This event was submitted by the user facility under this mdr number 1184621211-2024-0001.This report is related to the following linked patient identifiers: (b)(6).

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 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 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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the results of the legal manufacturer's (lm) final investigation and review of the customer cleaning disinfection and sterilization (cds) processes.Additionally, to provide a correction to field a2 and to provide an update to field d8.The lm reviewed the customers provided the cds processes where no obvious deviations from the instruction for use (ifu) were identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the relationship between the subject device and the reported event could not be identified.The root cause of the reported event could not be determined.The event can be prevented by following the instructions for use which state: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20345353
• MDR Text Key: 353074578
• Report Number: 9610595-2024-19697
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/23/2024

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?: No
• Initial Date Manufacturer Received: 09/05/2024
• Initial Date FDA Received: 10/01/2024
• Supplement Dates Manufacturer Received: 12/09/2024
• Supplement Dates FDA Received: 12/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White