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 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 2429304-2023-00150.
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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 bronchoalveolar lavage rll, results (b)(6) 2020 sarocladium species.Patient's current condition alive.
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