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

Model Number TJF-Q190V

Device Problem Device Reprocessing Problem (1091)

Patient Problem Unspecified Infection (1930)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus and sent to a third party for microbial contamination evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304-2022-00124.

Event Description

The customer reported to olympus, after three therapeutic procedures with the same subject device, three patients had unspecified infections.The device was then removed from use.The patients tested positive for: e coli, pseudomonas aeruginosa and candida albicans from an unknown culture source.The facility did not specify which patient had each microorganism.No atp testing was performed.The scope was reprocessed (b)(6) 2022, no delay in the start of pre-cleaning, water was aspirated through the instrument/suction channel with a suction pump, no abnormalities with the reprocessing accessories, manual cleaning was performed within an hour after the procedure or pre-soaking was completed, device passed the leak test, ezol detergent used, and all appropriate areas of the scope were brushed (air/water/suction/biopsy valve; suction, air/water, biopsy port, elevator).The customer's last reprocessing in-service by olympus was (b)(6) 2021 and there have not been any changes in personnel since then.The endoscope is being stored in a drying cabinet, hanging vertically with knobs on the free position.The aer used: medivators advantage plus ¿ serial #: (b)(4).Detergent and disinfect solutions used are intercept/rapicide pa.All channels were connected with tubes when the endoscope was connected to the aer.On 15 nov 2022, an olympus team member was dispatched and discussed the patient infections with the reprocessing technician.The reprocessing technician was unaware of anything unusual about the scope.The observation/in-service could not be performed that day and will take place (b)(6) 2022.This event includes 3 reports: (b)(6) : patient 1.(b)(6) : patient 2.(b)(6) : patient 3.

• 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: 15805805
• MDR Text Key: 303740696
• Report Number: 9610595-2022-04026
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Device Catalogue Number: N5992941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2020
• 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
• Patient Outcome(s): Other