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

Model Number BF-H190

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The hygiene microbiological investigation report indicated the channels of the scope were cultured and testing did not detect microbiological growth.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that during routine microbiological testing, the evis exera iii bronchovideoscope tested positive for 10 colony forming units (cfus) /ml of pseudomonas stutzeri, pseudomonas oryzihabitans, agrobacterium radiobacter, and coagulase-negative staphylococcus spp.In the biopsy channel.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the customer provided cleaning disinfection and sanitization (cds) practices, the device evaluation, and the legal manufacturer's final investigation.Additional details were received regarding the cleaning disinfection and sterilization practices (cds) of the user where there was no suspected patient infection and there are no deviations, concerns, or deficiencies regarding reprocessing.Precleaning: - performed immediately after the procedure.- water is aspirated through the instrument / suction channel with a suction pump until the aspirated liquid becomes clear.Manual cleaning: leak testing was performed and passed.The detergent used for manual cleaning is gigazyme xtra.The brushed points are unknown.It is unknown if the distal end is flushed with maj-2319.Disinfection: a getinge is used with aperlan poka-yoke agent b detergent and aperlan poka-yoke agent a disinfectant.There were no defects on the automatic endoscopic reprocessor (aer).All channels were connected with cleaning tubes when the endoscope was setting up into the aer.The disinfectant was used within its expiration date.The minimum effective concentration (mec) of the disinfectant solution was meet.The water quality of the rinse water was not controlled.The water filter was not replaced in accordance with the instructions for use (ifu).Storage: it is unknown how the device was dried.The device is stored in a drying cabinet.The device was evaluated where no abnormalities were found that could have led to the positive culture.A few defects were noted where the plastic distal end cover was damaged, the bending section rubber glue is separated, the connecting tube is dented, the angulation is less than the specified value and it also has play.However, these defects alone are not considered severe enough to cause a potential adverse event.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, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Type of Device: BRONCHOVIDEOSCOPE
• 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: 18024644
• MDR Text Key: 326794344
• Report Number: 9610595-2023-16028
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• 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