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 Type  malfunction  

Event Description

It was reported that the bronchovideoscope tested positive mycobacterium gordonae.The issue was found during an unspecified procedure.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

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

It is unknown whether the device was used on a patient with known infection of the same microorganism.The endoscope was not ethylene oxide gas (eto) sterilized.The endoscope is reprocessed with a non-olympus automated endoscope reprocessor (aer).The endoscope channel was brushed during manual cleaning.Pre-cleaning was performed immediately after a procedure using the following steps: wipe down with yellow enzymatic detergent sponge in sterile water, suction water with enzymatic for 30 seconds, suction air for 30 seconds, take buttons out and take to decontaminate for aer process within an hour.The endoscope is tested for leaks prior to manual cleaning.It was reported there were mechanical issues with the non olympus aer.The screens were messed up and the doors open.Preventative maintenance was last performed on the aer may 2024 which is done annually or when needed.The last reprocessing in-service conducted by an olympus endoscopy support specialist (ess) was march 4, 2024 for cleaning the scopes.There has been changes in the facilities' reprocessing personnel since the last olympus ess due to staff turnover but training was achieved during orientation with a checklist process.All reprocessing personnel are trained on how to properly reprocess an endoscope per the manufacturer's instructions for use manual.The endoscope is being stored with the non-olympus pass through system baskets with med gas hookups.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 2429304-2024-00254.This report is related to the following linked patient identifiers: (b)(6).

Event Description

It was reported there was a significant increase of mycobacterium gordonae positive cultures in bronchoscopy patients during (b)(6) 2023 through (b)(6) 2024.The sampling and culturing was performed because of the increase of positive mycobacterium gordonae bronchoscopy cultures.The particular scope was used one hundred three times.Seven out of the ten positive cases occurred with the subject device.It was later reported the procedure performed was a robotic assisted bronchoscopy and the patient was cultured on (b)(6) 2023.The patient did not warrant antibiotics.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19134335
• MDR Text Key: 341469617
• Report Number: 9610595-2024-08147
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335174
• UDI-Public: 04953170335174
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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