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

Model Number BF-1TH190

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

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

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

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 reprocessor (aer) treatment, the medivators 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)(6)).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 2429304-2023-00146.

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 march 20, 2018 and february 25, 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)(6), (b)(6) 2019.Patient 1 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2019.Patient 2 - (b)(6), bf-q190 / (b)(6), (b)(6) 2020.Patient 2 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2020.Patient 3 - (b)(6), bf-1t180 / (b)(6),admit: (b)(6) 2020, bronch: (b)(6) 2020.Patient 4 - (b)(6), bf-q190 / (b)(6), (b)(6) 2020.Patient 5 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2020.Patient 6 - (b)(6), bf-1th190 / (b)(6), (b)(6) 2020.Patient 6 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2020.Patient 7 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2020.Patient 8 - (b)(6), bf-1th190 / (b)(6), (b)(6) 2020.Patient 8 - (b)(6),bf-uc180f / (b)(6), (b)(6) 2020.Patient 9 - (b)(6), bf-q190 / (b)(6), (b)(6) 2020.Patient 10 - (b)(6), bf-1th190 / (b)(6), (b)(6) 2021.Patient 10 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2021.Patient 11 - (b)(6), bf-q190 / (b)(6), (b)(6) 2021.Patient 12- (b)(6), bf-1th190 / (b)(6), (b)(6) 2021.Patient 12 - (b)(6), bf-uc180f / (b)(6), (b)(6) 2021.Patient 13 - (b)(6), bf-1t180 / (b)(6), (b)(6) 2021.Patient 13 - (b)(6), bf-uc180f / (b)(6), (b)(6)2021.Patient 14 - (b)(6), bf-q190 / (b)(6), (b)(6)2021.Patient 15 - (b)(6), bf-p190 / (b)(6), (b)(6)2021.Patient 16 - (b)(6), bf-q190 / (b)(6), (b)(6)2022.This medwatch report is for patient identifier (b)(6): infection verified via bronchial washing, results (b)(6) 2020 sarocladium species, mycobacterium intracellulare.Patient's current condition alive.

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.Tjaden 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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, obvious deviation from the instruction manual regarding device reprocessing was not observed (per the information provided by the facility).Since the subject device was not returned for an evaluation, a culture test was not performed by olympus.Therefore, the reported issue could not be confirmed, and the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.¿ this supplemental report includes a correction to h4.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: 16969078
• MDR Text Key: 315741935
• Report Number: 9610595-2023-07783
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• 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,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BF-1TH190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 07/21/2023
• Supplement Dates FDA Received: 07/13/2023; 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• 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: 83 KG
• Patient Race: White