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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

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OLYMPUS AMERICA, INC. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number OLYMPUS GF TYPE UCT180
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Information (3190)
Event Date 04/30/2018
Event Type  malfunction  
Event Description
Upon performance of routine eus scope cultures, the scope was found to be positive for a cre - carbapenem resistant enterobacter. The last negative culture for this scope was (b)(6) 2018. Between (b)(6), the scope was used 11 times. The scope was sent out for repair and returned april 19, 2018 and was not used again up to the time of the routine eus scope culturing.
 
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Brand NameEVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
OLYMPUS AMERICA, INC.
3500 corporate parkway
center valley PA 18034 0610
MDR Report Key7595941
MDR Text Key110924704
Report Number7595941
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOLYMPUS GF TYPE UCT180
Device Catalogue NumberGF-UCT180
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/08/2018
Device Age7 YR
Event Location Hospital
Date Report to Manufacturer05/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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