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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEM CORPORATION OLYMPUS OES CYSTONEPHROFIBERSCOPE CYSTOSCOPE Back to Search Results
Model Number CYF-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

Olympus followed up with the user facility via telephone and in writing to gather additional information, however, only limited information was provided. The device returned to olympus for service with a report of heavy corrosion on the bending section and distal end. The evaluation confirmed the user report of heavy corrosion. The insertion tube had deep cuts and blisters, and the unit failed insulation testing. The instrument channel was also kinked. The device was serviced. As part of our follow-up into this report, an endoscopy support specialist (ess) visited the facility to assess the reprocessing practices and to provide in-service on how to properly reprocess endoscopes. Based upon the information provided by the ess, the facility was not to be reprocessing the device in accordance with the device instruction manual. The facility was not using enzymatic detergent during manual cleaning and was not performing leak testing. The ess provided training on proper reprocessing steps. The cause of the event could not be determined; however, not following reprocessing steps could likely contribute to the reported event.

 
Event Description

Oca undertook a retrospective review of its mdr files for the period of january 2005 to april 2015. Based upon this review, we are submitting this mdr to separately account for each of the seven patients involved in this event. The user facility reported seven cases of pseudomonas infections after having undergone a cystoscopy procedure. All of the patients were said to have required antibiotics for treatment, and three of the patients were hospitalized. The status of the patients is not currently known. Please cross reference mfr. Report numbers: 2951238-2016-00168, 2951238-2016-00170, 2951238-2016-00171, 2951238-2016-00172 and 2951238-2016-00173 to account for the six patients as referenced in the original report. The following report will be supplemented to cross reference the six associated infection complaints: 9610773-2010-00027.

 
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Brand NameOLYMPUS OES CYSTONEPHROFIBERSCOPE
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEM CORPORATION
2951 ishikawa-cho,
hachioji-shi
tokyo 192-8 507
JA 192-8507
Manufacturer Contact
donny shapiro
2400 ringwood avenue
san jose, CA 95131
4089355161
MDR Report Key5468086
MDR Text Key39303705
Report Number2951238-2016-00169
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK993041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 02/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-5
Device Catalogue NumberCYF-5
Device LOT NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/30/2010
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2010
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: 02/29/2016 Patient Sequence Number: 1
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