OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2010-09-29 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.

Event Text Entries

[1433590] Olympus received a report from the user facility that alleged there were a total of seven patients that had developed urinary (b)(6) infections, and it was not known which of four devices had been alleged to be the source of the infections. The subject device had reportedly been cultured at the user facility, and tested negative. There was no further information provided regarding the status of the patients.
Patient Sequence No: 1, Text Type: D, B5


[8740305] Olympus followed up with the user facility via phone and in writing to gather more information for this report. The first infection was said to have been identified on (b)(6)2010, but no additional information regarding the status of the patients or the alleged infections was provided. The subject device of this report was forwarded to an independent microbiological testing laboratory for culturing followed by ethylene oxide sterilization. Olympus has been informed that the scope tested negative for growth. Following culturing, the device was forwarded to olympus for evaluation. The instrument channel was examined, and a reddish-orange residue was found inside the device. The evaluation also found that the device failed leak testing at the control body. At the present time, the exact cause of the reported phenomenon cannot be determined, however, insufficient reprocessing and/or user handling cannot be ruled out as contributory factors. The device is awaiting approval from the user facility for service to be performed. If significant additional information is received, a supplemental report will follow. This is report one of four. Please see also mfr#s: 8010047-2010-00184, 8010047-2010-00185 and 8010047-2010-00186. (b)(4)
Patient Sequence No: 1, Text Type: N, H10


[39854775] 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 supplemental report to separately account for each of the ten patients involved in this event. In addition, this supplemental report is being submitted to provide device evaluation results for the following devices: cyf-5 with serial# (b)(4), cyf-5 with serial# (b)(4), and cyf-5 with serial# (b)(4). Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found deep cuts in the insertion tube. Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found a leak at the air valve. Cyf-5 sn# (b)(4): the device was forwarded to a laboratory for microbiological testing. The device tested negative for growth. The device was forwarded to olympus for evaluation following the laboratory microbiological testing. The evaluation found white residue in the instrument channel port and on the distal end of the device. The evaluation also found 8 broken image fibers and a leak at the eto valve. Based on the device evaluation results, the most likely cause of the reported events is due to improper maintenance of the device. Please cross reference mfr. Report numbers: 8010047-2010-00184, 8010047-2010-00185, 8010047-2010-00186, 2951238-2016-00155, 2951238-2016-00156, 2951238-2016-00157, 2951238-2016-00158, 2951238-2016-00159, and 2951238-2016-00160 to account for the ten patients as referenced in the original report.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010047-2010-00190
MDR Report Key1853287
Report Source06,USER FACILITY
Date Received2010-09-29
Date of Report2016-03-04
Date of Event2016-08-10
Date Mfgr Received2010-08-31
Date Added to Maude2010-10-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4848965688
Manufacturer G1OLYMPUS MEDICAL SYSTEMS CORPORATION
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO 192-8507
Manufacturer CountryJA
Manufacturer Postal Code192-8507
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOLYMPUS OES CYSTONEPHROFIBERSCOPE
Generic NameCYSTONEPHROFIBERSCOPE
Product CodeGCQ
Date Received2010-09-29
Returned To Mfg2010-09-23
Model NumberCYF-5
Lot NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORPORATION
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-09-29

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