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: patient 1 - (b)(6), model#/ serial #/ procedure date: bf-q190 / (b)(6); patient 1 - (b)(6), bf-uc180f / (b)(6); patient 2 - (b)(6), bf-q190 / (b)(6); patient 2 - (b)(6), bf-uc180f / (b)(6); patient 3 - (b)(6), bf-1t180 / (b)(6); admit: (b)(6), bronch: (b)(6), patient 4 - (b)(6), bf-q190 / (b)(6); patient 5 - (b)(6), bf-uc180f / (b)(6); patient 6 - (b)(6), bf-1th190 / (b)(6); patient 6 - (b)(6), bf-uc180f / (b)(6); patient 7 - (b)(6), bf-uc180f / (b)(6); patient 8 - (b)(6), bf-1th190 / (b)(6); patient 8 - (b)(6), bf-uc180f / (b)(6); patient 9 - (b)(6), bf-q190 / (b)(6); patient 10 - (b)(6), bf-1th190 / (b)(6); patient 10 - (b)(6), bf-uc180f / (b)(6); patient 11 - (b)(6), bf-q190 / (b)(6); patient 12- (b)(6), bf-1th190 / (b)(6); patient 12 - (b)(6), bf-uc180f / (b)(6); patient 13 - (b)(6), bf-1t180 / (b)(6); patient 13 - (b)(6), bf-uc180f / (b)(6); patient 14 - (b)(6), bf-q190 / (b)(6); patient 15 - (b)(6), bf-p190 / (b)(6); patient 16 - (b)(6), bf-q190 / (b)(6); this medwatch report is for patient identifier (b)(6): infection verified via bronchoalveolar lavage rul, results (b)(6)2022 sarocladium / acremonium species confirmed mycobacterium gordonae.Patient's current condition alive.
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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.
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