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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-5
Device Problem Device Reprocessing Problem (1091)
Patient Problem Urinary Tract Infection (2120)
Event Date 08/31/2012
Event Type  Other  
Manufacturer Narrative
Olympus followed-up with the user facility to obtain additional info regarding this report. The user facility reported that three male pts who had undergone flexible cystoscopy procedure on (b)(6) 2012 had reportedly developed uti with symptoms such as frequency and urgency during urination. Two of the three male pts reportedly went to the er and were provided with antibiotics, and the third pt reportedly was provided with antibiotics by the on-call physician. The user facility reported that the incidences might have been related to their inability to properly clean the referenced device. The user facility reported that the referenced device had never been returned to olympus for service since 2010. An olympus endoscopy support specialist (ess) had conducted an in-service. The ess reported that the user facility was not performing pre-cleaning and leaking testing. Additionally, manual cleaning only consisted of washing the endoscope in detergent and brushing the channel with no flushing performed. High level disinfection consisted of partially submerging the endoscope in cidex. The device referenced in this report was returned to olympus for eval. The eval found slight white residue and debris inside the channel mount unit and at the distal end of the biopsy channel. There was residue or biomaterial buildup on the bending cover. Additionally, peeling was noted on the insertion tube and the bending cover was leaking due to there was a cut at 39mm from the distal tip. The cause of this report appears to be related to user error. This is one of three reports. Please ref 8010047-2012-00369 and 8010047-2012-00370. This report is being submitted as a medical device report in an abundance of caution.
 
Event Description
Olympus was informed that three male pts developed urinary tract infection (uti) following the use of the referenced device.
 
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Brand NameOLYMPUS OES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer (Section G)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachioji-shi, tokyo 192- 8507
JA 192-8507
Manufacturer Contact
laura storms-tyler
2400 ringwood ave
san jose, CA 95131
4848965688
MDR Report Key2818381
MDR Text Key10282264
Report Number8010047-2012-00371
Device Sequence Number1
Product Code GCQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/04/2012
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2012
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCYF-5
Device Catalogue NumberCYF-5
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/25/2012
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/04/2012
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: 10/03/2012 Patient Sequence Number: 1
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