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 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.

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.

• 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
• MDR Report Key: 16970247
• MDR Text Key: 315742274
• Report Number: 2429304-2023-00153
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335198
• UDI-Public: 04953170335198
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023,07/13/2023

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?: Yes
• Distributor Facility Aware Date: 04/20/2023
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: White