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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-1T180
Device Problems Endoscope; Microbial Contamination of Device
Event Type  Injury  
Manufacturer Narrative

The user facility further reported on (b)(6) 2017 that they have no plans in returning the scope to olympus for evaluation. In addition, the user facility reported that the frequency of use for the scope is approximately 10 times a month from (b)(6) through mid (b)(6) 2016. It was also reported that a non olympus accessory (covidien (b)(4)) was attached to the biopsy port. A non olympus medivator dsd automated endoscope reprocessor (aer) machine alongside medivator scope buddy connector is used to reprocess the scope. The scope is hung in a ventilated cabinet to dry. It was also reported that the (b)(4) patients that tested positive for pseudomonas aeruginosa underwent bronchoscopy procedures in (b)(6) and (b)(6) of 2016. The date that the infections were confirmed was on (b)(6) 2016. In addition, the original equipment manufacturer (oem) performed a reproduction test on a bf-1t180 scope with a similar non olympus medtronic edge adapter borrowed from the user facility. It was found that the instrument channel port of the bf-1t180 scope did not come loose.

 
Event Description

Olympus was informed that 13 patients tested positive for pseudomonas aeruginosa. Approx 2 out of the 13 patients were identified as having comorbidity medical conditions and have since expired. The dates of the two deaths are unknown. It was also reported that medical intervention was provided to the patients; however, no details were provided. In addition, the bronchovideoscope tested positive for pseudomonas aeruginosa after reprocessing. There was biomatter found underneath the o-ring of the scope. The scope was removed from service on september 16, 2016. This is 3 of 13 reports.

 
Manufacturer Narrative

The device has not been returned to olympus for evaluation. The user facility and olympus is arranging a date to visit the site to observe an unidentified organization gather cultures from the bronchoscope as part of their investigation of the reported events. In addition, an olympus endoscopy support specialist (ess) visited the user facility on october 19, 2016 to assess their reprocessing practices and provided reprocessing training. The ess found the following reprocessing deviations: the user facility was not suctioning the scope after manual brushing. Instead, the user facility was using a non olympus endoscope flushing aid (scope buddy manufactured by (b)(4)) to flush the channels of the scope. The cause of the reported positive culture could not be determined but improper maintenance of the device cannot be ruled out as a contributory factor. Chapter 3 of the reprocessing instruction manual states, ¿turn the suction pump on. When using the biopsy valve (md-495), attach the biopsy valve¿s cap. Immerse the distal end of the insertion section in detergent solution. Depress the suction valve and aspirate detergent solution into the instrument channel for 30 seconds. ¿.

 
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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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose , CA 95131
408935-512
MDR Report Key6077932
Report Number2951238-2016-00826
Device Sequence Number1
Product CodeEOQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation RISK MANAGER
Type of Report Initial,Followup
Report Date 01/19/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberBF-1T180
Device Catalogue NumberBF-1T180
Device LOT NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/27/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 11/03/2016 Patient Sequence Number: 1
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