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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERAII BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-Q180
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The scope was returned to the service center and is pending evaluation. The cause of the reported event cannot be determine at this time. As part of our investigation of this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess their reprocessing practices and to provide reprocessing training if necessary. To date, the ess visit has not been finalized.

 
Event Description

The service center was informed that on (b)(6) 2020 culture samples were taken from the scope after reprocessing. The user facility reported that results received on (b)(6) 2020, show the scope cultured positive for positive for stenotrophomonas maltophilia. The scope was cultured twice and both results were positive. There was no patient involvement reported.

 
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Brand NameEVIS EXERAII 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 Key11012132
MDR Text Key221556562
Report Number8010047-2020-10390
Device Sequence Number1
Product Code EOQ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK061313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/01/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBF-Q180
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/19/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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