OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5- CYF-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-08-23 for OLYMPUS OES CYSTONEPHROFIBERSCOPE CYF-5- CYF-5 manufactured by Olympus Medical Systems Corp..

Event Text Entries

[2989610] Olympus was informed that two of the cystoscopes were found to have rust at the distal end which attributed to pts with excessive pain post-operative. There were no further details provided.
Patient Sequence No: 1, Text Type: D, B5


[10217155] Olympus followed-up with the user facility to obtain add'l info regarding this report. The user facility reported that 3 pts reportedly had experienced pain after having undergone cystoscopy procedures with the use of their cystoscopes. The user facility reportedly could not determine which endoscope that the pt was complaining about burning during urination immediately following the procedure. The pt reportedly was provided with pyridium and tramadol and was instructed to take ibuprofen. The pt's condition reportedly was improving as reported on (b)(6) 2012. The user facility reportedly identified rust at the distal end of the cystoscopes after receiving complaints from pts relative to burning pain during urination. The device referenced in this report was returned to olympus for eval. The eval found the bending section of the device was stained. The device passed the leakage testing and the insulation testing. As part of the investigation into this report, an olympus endoscopy support specialist was dispatched to the facility to provide in-servicing on appropriate reprocessing. The reported phenomenon was attributed to insufficient cleaning and improper reprocessing. This is one of these reports. Please also reference 8010047-2012-00296 and 00297. This report is being submitted as a medical device report in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010047-2012-00295
MDR Report Key2718810
Report Source06,07
Date Received2012-08-23
Date of Report2012-07-26
Date of Event2012-07-16
Date Mfgr Received2012-07-26
Date Added to Maude2012-09-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAURA STORMS-TYLER
Manufacturer Street2400 RINGWOOD AVENUE
Manufacturer CitySAN JOSE CA 95131
Manufacturer CountryUS
Manufacturer Postal95131
Manufacturer Phone4848965688
Manufacturer G1OLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Street2951 ISHIKAWA-CHO HACHIOJI-SHI
Manufacturer CityTOKYO 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 NameCYSTOSCOPE
Product CodeGCQ
Date Received2012-08-23
Returned To Mfg2012-08-03
Model NumberCYF-5-
Catalog NumberCYF-5
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI TOKYO 192-8507 JA 192-8507


Patients

Patient NumberTreatmentOutcomeDate
10 2012-08-23

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