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

Model Number TJF-Q190V

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem Bacterial Infection (1735)

Event Date 10/17/2022

Event Type  Injury  

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
• MDR Report Key: 15805429
• MDR Text Key: 303753387
• Report Number: 2429304-2022-00126
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170452024
• UDI-Public: 04953170452024
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/02/2022,11/16/2022

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?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other