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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM

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OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS EVIS EXERA III VIDEO SYSTEM ENDOSCOPIC VIDEO IMAGING SYSTEM Back to Search Results
Model Number PCF-H190L
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2014
Event Type  Other  
Manufacturer Narrative
The device was sterilized at the user facility prior to being returned to olympus for evaluation. The biopsy chanel and the suction channel were checked with a baroscope and scrape marks were found in the biopsy channel. In addition, there was fluid invasion in the scope connector and light guide prong. The device was serviced and returned to the user facility. The exact cause of the user's report could not be conclusively determined. This reported will be supplemented if additional and relevant info becomes available at later time. An olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the user facility's reprocessing practices. No reprocessing deviations were noted. Please cross-reference the following reports for the other four colonoscopes: 2951238-2014-00034, 2951238-2014-00035, 2951238-2014-00037, and 2951238-2014-00038.
 
Event Description
Olympus was informed that five colonoscopes tested positive for klebsiella, citrobacter, pseudomonas, stenotrophomonas, e. Coli, enterococcus and other non-specified gram negative bacteria. The user facility cultured the device as part of their microbiological surveillance testing. The device was reprocessed in a non-olympus automatic endoscope reprocessor prior to conducting the test. There was no pt infection associated with this report.
 
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Brand NameOLYMPUS EVIS EXERA III VIDEO SYSTEM
Type of DeviceENDOSCOPIC VIDEO IMAGING SYSTEM
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho, hachioji-shi
tokyo 192- 8507
JA 192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho, hachioji-shi
tokyo 192- 8507
JA 192-8507
Manufacturer Contact
laura storms
2400 ringwood ave.
san jose, CA 95131
4848965688
MDR Report Key3652377
MDR Text Key11574815
Report Number2951238-2014-00036
Device Sequence Number1
Product Code FDF
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/13/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPCF-H190L
Device Catalogue NumberPCF-H190L
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/16/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/13/2014
Was Device Evaluated by Manufacturer? Yes
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: 01/31/2014 Patient Sequence Number: 1
Treatment
REPROCESSOR) S/N # UNK; MEDIVATORS DSD EDGE (AUTOMATIC ENDOSCOPE
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