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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UCT180
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The medwatch report provided an incorrect serial number for the model gf-uct180 scope; therefore, it is unknown if the device was returned olympus for evaluation and/ or service. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available at a later time, this report will be updated accordingly.
 
Event Description
Olympus received a medwatch report which states that during routine culturing the scope tested positive for positive for a carbapenem-resistant enterobacteriaceae (cre). According to the report, the scope last cultured negative on (b)(6) 2018. The scope has been used 11 times between (b)(6) and (b)(6). The scope was reportedly returned to the manufacturer for repair on april 19, 2018 and was not utilized again up to the time of the routine scope culturing. There were no associated patient infections reported.
 
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Brand NameEVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
Type of DeviceULTRASOUND GASTROVIDEOSCOPE
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 Key7924721
MDR Text Key122465828
Report Number2951238-2018-00589
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGF-UCT180
Device Catalogue NumberGF-UCT180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
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

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