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 10/16/2023

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 yet been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The microbiological analysis results are still pending.The cleaning, disinfection, and sterilization (cds) was performed by the customer.The customer confirmed that there were no deviations or deficiencies concerning reprocessing of the scope.Additionally, the customer confirmed that there were no suspected patient infections due to the facility findings.The device was reprocessed between each sampling, and prior to the final sampling, the device was manually high-level disinfected with cidex-opa disinfectant.The customer provided the cleaning, disinfection, and sterilization process stating that precleaning was performed immediately after the procedure with the following steps: ensure insertion rotating ring is in the aligned position; turn off the light source; ensure biopsy cap is closed; wipe the control handle then outer surface of insertion tube with an enzymatic detergent soaked sponge (first step by cygnus); place the distal end of insertion tube into enzymatic detergent (first step by cyngus); suction all 500ml enzymatic detergent in the first step bag (minimum 10 seconds); aspirate air for 10 seconds by depressing the suction valve; turn suction source to off; remove suction tube from suction connector of the suction valve; turn off the processor then remove bronchoscope; transport bronchoscope to reprocessing area.Prior to manual cleaning, leak testing was performed using an olympus leak tester.During manual cleaning, the endoscope channels were brushed using a single use cleaning brush from boston scientific and olympus.The automated endoscope reprocessor (aer) used were medivators advantage plus aers with ruhoff¿s endozime aw plus detergent and medivator¿s rapicide pa disinfectant.The minimum effective concentration was checked each reprocessing cycle.Preventative maintenance was completed within the last year on each of the aers used and there were no reported equipment problems.The water quality was controlled and the filter was replaced periodically in accordance with the instructions for use.The device was stored in medivators endodry horizontal drying cabinet.Olympus is the maintenance company.All facility personnel are trained on how to properly reprocess an endoscope but the customer reported there had been changes in the reprocessing personnel since the last olympus endoscopy support specialist (ess) on-site reprocessing in-service visit.As part of the investigation into this report, an olympus ess has been dispatched on-site to assess the reprocessing practices at the user facility.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 culture testing, the evis exera iii bronchovideoscope tested positive for microbiological contamination in three samples.On (b)(6) 2023, testing detected 1-10 colony forming units (cfus) of achromobacter xylosoxidans and 1-10 cfu of micrococcus lueus, on (b)(6) 2023 testing detected >100 cfu of achromobacter xylosoxidans, and on (b)(6) 2023 testing detected 1-10 cfu of achromobacter xylosoxidans.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 results of third-party testing, the device evaluation and the legal manufacturer's final investigation.Olympus provided the following result of the culture test, performed at the third-party labs: sampling date: nov.15, 2023.Sampling from: insertion section.Cfu: unknown.Bacterial identification: actinomyces species.Sampling from: instrument/suction channel.Cfu: unknown.Bacterial identification: sporosarcina thermotolerans.The device was evaluated where no abnormalities were found that could have led to the positive culture.The following defects were noted: bending section - conduction failure between distal end and connector.Control body - customer label on angulation low.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.The following is included in the device ifu: "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 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: 18125208
• MDR Text Key: 329202374
• Report Number: 9610595-2023-17082
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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
• Date Returned to Manufacturer: 10/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2015
• 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