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

Model Number BF-Q190

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Fungal Infection (2419)

Event Date 12/12/2019

Event Type  Injury  

Event Description

The customer reported to olympus, the evis exera bronchovideoscope bronch wash tested positive for sarocladium during a routine culture of the scope.The sampling was taken at reprocessing, before use.Additional information received indicated there were 16 patients with positive culture results between (b)(6) 2018 and (b)(6) 2022.None of the patients were treated for this organism.The following medwatch reports are related: complaint numbers model#/ serial # procedure date patient 1 - (b)(6) bf-q190 / (b)(4) (b)(6) 2019 patient 1 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2019 patient 2 - (b)(6) bf-q190 / (b)(4) (b)(6) 2020 patient 2 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2020 patient 3 - (b)(6) bf-1t180 / (b)(4) admit: 1(b)(6) 2020, bronch: (b)(6) 2020 patient 4 - (b)(6) bf-q190 / (b)(4) (b)(6) 2020 patient 5 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2020 patient 6 - (b)(6) bf-1th190 / (b)(4) (b)(6) 2020 patient 6 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2020 patient 7 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2020 patient 8 - (b)(6) bf-1th190 / (b)(4) (b)(6) 2020 patient 8 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2020 patient 9 - (b)(6) bf-q190 / (b)(4) (b)(6) 2020 patient 10 - (b)(6) bf-1th190 / (b)(4) (b)(6) 2021 patient 10 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2021 patient 11 - (b)(6) bf-q190 / (b)(4) (b)(6) 2021 patient 12- (b)(6) bf-1th190 / (b)(4) (b)(6) 2021 patient 12 -(b)(6) bf-uc180f / (b)(4) (b)(6) 2021 patient 13 - (b)(6) bf-1t180 / (b)(4) (b)(6) 2021 patient 13 - (b)(6) bf-uc180f / (b)(4) (b)(6) 2021 patient 14 - (b)(6) bf-q190 / (b)(4) (b)(6) 2021 patient 15 - (b)(6) bf-p190 / (b)(4) (b)(6) 2021 patient 16 - (b)(6) bf-q190 / (b)(4) (b)(6) 2022 this medwatch report is for patient identifier (b)(6) : infection verified via bronchoalveolar lavage rll, results (b)(6) 2020 sarocladium species.Patient's current condition alive.

Manufacturer Narrative

The events were discovered with the culture results as identified for the patient listed in b5.The user facility provided additional information regarding the cleaning, the disinfection and the sterilization processes performed onsite for the endoscopes.Accordingly, to the customer the scope was reprocessed after every use with no delay, and water was aspirated through the instrument/suction channel with a suction pump.No abnormalities were found with the reprocessing accessories and the scope passed leak testing.Manual cleaning was also performed 1 hr.After the procedure and the scope instrument/suction/balloon channel, air/water/suction/biopsy valve were brushed, and pure (boston scientific) detergent solution was used.For automated endoscope preprocessor (aer) treatment, the mediators reprocessor along with intercept plus detergent and rapacide pa disinfectant were used.The reprocessor and the scope were not tested.As part of their own investigation, the facility invited state surveyors to come and investigate their processes which did not turn up any definitive conclusions as to the cause of these positive cultures.The customer decided to send one scope to olympus (b)(6) bf-q190 / (b)(4) depending on findings, the facility will discuss and decide on the need to send the additional scopes in for investigation.The scope was sent to nelson lab by olympus for independent culture testing.The customer reported that the last reprocessing in-service conducted by an olympus endoscopy support specialist was (b)(6) 2022.An olympus endoscopy support specialist (ess) visit was scheduled for a future date to observe the user facility¿s reprocessing practices from start to finish and provide reprocessing in-service training.The investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.This report has been submitted by the importer under this mdr report number 2429304-2023-00153.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from the customer and to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: b5 and h6.A review of the device history record (dhr) confirmed that the subject device was shipped in accordance with the specifications.Based on the results of the investigation, the root cause of this phenomenon could not be identified.In this case there are 16 infected patients with most of them sarocladium fungi in the bronchoalveolar lavage (bal) samples.These patients were treated with 6 different olympus bf-endoscopes.Bf endoscopes varied in series (190 and 180) but also in model (p/q/1t/ebus).Olympus hygiene microbiological investigation (hmi) did not show the sarocladium but only staphylococcus epidermis.No proper cleaning, disinfection, and sterilization (cds) checklist was supplied.The chance that 6 different bf endoscopes infected the patients is possible but there can also be many other reasons for the infections.The instructions for use (ifu) warns on insufficient reprocessing by stating ¿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 the field performance of this device.

Event Description

Additional information received indicating all the reported scopes were utilized on patents who had positive cultures for sarocladium post bronchoscopy procedure.The facility has not identified sarocladium in the scopes themselves.All of these cases were determined by dr.(b)(6) to not actually be infected as no signs or symptoms correlated with a fungal infection, no treatment or medical intervention done.There were no nosocomial infection cases in the hospital, involving the same microorganisms detected in the reported patients, during the period between 2019 and 2022.There no evidence found of contamination of bronchoalveolar lavages during collection and/or microbiological culture at this time.

• 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: 16970281
• MDR Text Key: 315742351
• Report Number: 9610595-2023-07802
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335198
• UDI-Public: 04953170335198
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-Q190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White