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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 Problem Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
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.Original complaint: patient 1 of 5 is reported in case with patient identifier (b)(4).Patient 2 of 5 is reported in case with patient identifier (b)(4).Patient 3 of 5 is reported in case with patient identifier (b)(4).Patient 4 of 5 is reported in case with patient identifier (b)(4).Patient 5 of 5 is reported in case with patient identifier (b)(4).
 
Event Description
Correction to g3 of the initial medwatch.The aware date should be 01-apr-2021.
 
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Brand Name
EVIS EXERA III BRONCHOVIDEOSCOPE
Type of Device
BRONCHOVIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11814387
MDR Text Key253122465
Report Number2951238-2021-00333
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170335181
UDI-Public04953170335181
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 04/23/2021,12/07/2022
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
Device Operator Health Professional
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? Yes
Distributor Facility Aware Date04/23/2021
Event Location Hospital
Date Report to Manufacturer04/23/2021
Initial Date Manufacturer Received 05/12/2021
Initial Date FDA Received05/12/2021
Supplement Dates Manufacturer Received05/12/2021
Supplement Dates FDA Received12/07/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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