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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EUS ENDOSCOPIC ULTRASOUND CENTER; UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EUS ENDOSCOPIC ULTRASOUND CENTER; UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER Back to Search Results
Model Number EU-ME2 PREMIER PLUS
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2019
Event Type  malfunction  
Manufacturer Narrative
The subject eu-me2 premier plus has not returned to olympus medical systems corp.(omsc) for evaluation yet.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
During the ebus-tbna with the eu-me2 premier plus, the error cord ¿es9a08¿ was displayed on the ultrasound image of the monitor.The user canceled the ebus-tbna.There was no report of the patient injury other than above.
 
Manufacturer Narrative
The subject eu-me2 premier plus was not returned to olympus medical systems corp.(omsc) for evaluation.The information of error es9a08 was wrong.The correct error code was us9a08.The error us9a08 means that version of the software of eu-me2 premier plus is not appropriate for connecting endoscope.When using eu-me2 premier plus in combination with bf-uc290f, the software of eu-me2 premier plus needs to be updated to version 5.1 by service engineer.Therefore omsc concluded that this phenomenon occurred because the software of the subject device was not version 5.1.
 
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Brand Name
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER
Type of Device
UNIVERSAL ENDOSCOPIC ULTRASOUND CENTER
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key8407187
MDR Text Key139328238
Report Number8010047-2019-01241
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
PMA/PMN Number
K130058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 04/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEU-ME2 PREMIER PLUS
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/15/2019
Initial Date FDA Received03/11/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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