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

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).

• 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 Key: 11814387
• MDR Text Key: 253122465
• Report Number: 2951238-2021-00333
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170335181
• UDI-Public: 04953170335181
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• 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

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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?: Yes
• Distributor Facility Aware Date: 04/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2021
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

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