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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-1TH190
Device Problems Peeled/Delaminated (1454); Material Twisted/Bent (2981)
Patient Problem Respiratory Tract Infection (2420)
Event Type  Injury  
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 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).
 
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.
 
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Brand NameEVIS EXERA III BRONCHOVIDEOSCOPE
Type of DeviceBRONCHOVIDEOSCOPE
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 Key11815524
MDR Text Key261053542
Report Number8010047-2021-06230
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBF-1TH190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 05/12/2021 Patient Sequence Number: 1
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