MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III BRONCHOVIDEOSCOPE

Model Number	BF-1TH190
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.Preliminary findings are reported.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.Physical evaluation of the complaint device reveals: the rubber glue is chipped/lifted.There is a kink inside the forceps channel.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# (b)(4).
Event or Problem Description
It is reported an unknown time period after a procedure using an evis exera iii bronchovideoscope, the patient experienced an infection.The customer stated, it was initially very concerning that the same scope was used on 5 of the 6 patients in this potential pseudo-epidemic.However, there was no growth from the bronchoscope tip submerged for enrichment in tryptic soy broth, nor from sterile saline rinses passed through the upper and lower channels and plated onto blood agar, sabaroud dextrose agar, 7h11 agar and 7h9 broth in an attempt to recover non-fastidious bacteria, fungi and mycobacteria.After initial cultures were set up, we asked that the scope be removed from use and returned to the vendor for inspection since it had failed leak tests twice within a 6 month interval last year, and subsequently had channels replaced by the vendor.The concern was that damage or gaps in components might retain bioburden and lead to high level disinfection failure.I have not heard anything yet regarding the vendor¿s inspection, but it is reassuring that initial culture does not point to an obvious issue with this scope.It is possible that hld failures could be infrequent/intermittent so it will be good to review work practices to ensure we¿re consistently following protocol.Rather than an indication of infection risk, it may be that this scope is preferentially used.Patient 1 of 5 is reported in case with patient identifier (b)(6).Patient 2 of 5 is reported in case with patient identifier (b)(6).Patient 3 of 5 is reported in case with patient identifier (b)(6).Patient 4 of 5 is reported in case with patient identifier (b)(6).Patient 5 of 5 is reported in case with patient identifier (b)(6).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation.The legal manufacturer performed an investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause could not be identified.No germs were confirmed from the scope.It was likely that contamination occurred during sampling from the patients or culturing.There was no information on occurrence of infection from sampling of the patients.Atypical mycobacteria were not detected from the scope.The subject scope was frequently used for procedures.Even though the scope was used for the five patients, it did not indicate that the scope caused cross-contamination.No trace of bioburden was confirmed from the biopsy channel of the subject scope.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 01-apr-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: EVIS EXERA III BRONCHOVIDEOSCOPE
• Common Device Name: BRONCHOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11815524
• Report Number: 8010047-2021-06230
• Device Sequence Number: 15750749
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: BF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/13/2021; 11/08/2022
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 07/16/2021; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown