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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-H190
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2017
Event Type  malfunction  
Manufacturer Narrative
The subject device in this report has not yet been returned to omsc for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that during a surveillance culturing at the user facility the subject device tested positive for staphylococcus non aureus (43 cfu).There was no report of infection associated with this report.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation result.(b)(4) sent the subject device to a third party laboratory for additional microbiological testing.In the test, the biopsy channel of the subject device tested positive for staphylococcus coagulase -negative (2 cfu /endoscope).The result of the additional microbiological testing by a third party laboratory satisfied the french guideline.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code" and "pma/510(k) number".
 
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Brand Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6766006
MDR Text Key81907031
Report Number8010047-2017-01153
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
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 NumberGIF-H190
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2017
Initial Date FDA Received08/03/2017
Supplement Dates Manufacturer Received08/03/2017
02/13/2019
Supplement Dates FDA Received08/23/2017
02/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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