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 01,06,foreign,user facility report with the FDA on 2012-10-03 for OES CYSTONEPHROFIBERSCOPE CYF-5 manufactured by Olympus Medical Systems Corporation.

Event Text Entries

[3082094] Olympus was informed that four patients got prostatitis after having undergone a cystoscopy. There was no information provided regarding what, if any, treatment had been provided to the patients.
Patient Sequence No: 1, Text Type: D, B5


[10432484] Olympus sales representative visited the user facility and reviewed the user facility's reprocessing method and noted that the users didn't completely put the device in disinfection solution, brushes weren't exchanged regularly, and were worn out. The subject device was not returned to olympus for evaluation. The evaluation found slight residue in the instrument channel port and the distal end. At the present time, the exact cause of the reported phenomenon cannot be determined, however insufficient reprocessing and user handling cannot be ruled out as contributory factors. If significant additional information is received, a supplemental report will follow. This report is being submitted as a medical device report in an abundance of caution. Cross reference mfr report# 8010047-2012-00343, 8010047-20344, 8010047-2012-00345.
Patient Sequence No: 1, Text Type: N, H10


[36612051] Olympus medical systems corporation (omsc) performed a mdr retrospective review and omsc found that this supplemental report is required on december 24, 2015. This supplemental report is being submitted to provide the review result for the manufacture history of the subject device, put check mark in "other serious", correct from "other" to "serious injury", and delete incorrect description stating that "the evaluation found slight residue in the instrument channel port and the distal end". Omsc reviewed the manufacture history of the subject device, there was no irregularity found. Please cross-reference mfr. Report# 8010047-2012-00343, 8010047-2012-00344, 8010047-2012-00345.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010047-2012-00346
MDR Report Key2796858
Report Source01,06,FOREIGN,USER FACILITY
Date Received2012-10-03
Date of Report2016-01-21
Date Mfgr Received2012-09-13
Date Added to Maude2012-10-25
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 ContactSUSUMU NISHINA
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOES CYSTONEPHROFIBERSCOPE
Generic NameCYSTOSCOPE
Product CodeGCQ
Date Received2012-10-03
Model NumberCYF-5
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
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 2012-10-03

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