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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-P190
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. The scope was returned to olympus for evaluation; however, the device evaluation is still pending completion. The scope will be sent to our independent laboratory for microbial testing and ethylene oxide (eto) sterilization. In addition, an olympus endosocpy support specialist (ess) visited the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training. The ess observed only one minor reprocessing deviation. The staff used a 30cc syringe to aspirate 90cc of fluid into the scope. The scope is reprocessed in a non-olympus automated endoscope reprocessor (aer) and stored in a scope cabinet. The ess provided the user facility staff a reprocessing wall chart and a dvd step by step video on how to reprocess a bronchoscope. This report will be supplemented when the device evaluation has been completed and if additional information becomes available at a later time.

 
Event Description

Olympus was informed that an unspecified carbapenem-resistant enterobacteriaceae (cre) outbreak occurred at the user facility with multiple patients. The physicians are unsure if the scope caused or contributed to the patient infection outbreak.

 
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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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose , CA 95131
4089355124
MDR Report Key7559224
Report Number2951238-2018-00326
Device Sequence Number1
Product CodeEOQ
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 11/20/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBF-P190
Device Catalogue NumberBF-P190
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/02/2018
Was Device Evaluated By Manufacturer? Yes
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: 05/31/2018 Patient Sequence Number: 1
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