CYSTO-NEPHRO VIDEOSCOPE CYF-VHA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-25 for CYSTO-NEPHRO VIDEOSCOPE CYF-VHA manufactured by Olympus Medical Systems Corp..

Event Text Entries

[112140659] The subject device was returned to olympus for evaluation. The evaluation confirmed foreign materials within the instrument channel port and a deformation in the instrument channel of the subject device. Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present, but the insufficient reprocessing by the user facility cannot be ruled out as the cause of this event.
Patient Sequence No: 1, Text Type: N, H10


[112140660] Olympus medical systems corp. (omsc) was informed that three of six patients, who undergone unspecified cystoscopy with the subject device, suffered mild prostatitis since they purchased the subject device on (b)(6) 2018. It was reported that the three patients were treated with antibiotic and in good condition after the procedure. The facility reported that they had used another cystoscope before (b)(6) and there was no prostatitis. Omsc followed up with the facility to obtain additional information. The facility reported that they manually reprocessed the subject device using glutaraldehyde and the subject device passed the leakage test during reprocessing. In addition following deviations from the instructions of the subject device were reported from the facility. -the facility did not use medical detergent solution but a detergent solution for household. -they did not attached adapter to the channels of the subject device during the reprocessing and they flush the channels directly using running water. This is one of three repots.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010047-2018-01208
MDR Report Key7633183
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2018-06-25
Date of Report2019-02-26
Date Mfgr Received2019-02-13
Device Manufacturer Date2018-01-18
Date Added to Maude2018-06-25
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 ContactMR KAZUTAKA MATSUMOTO
Manufacturer Street2951 ISHIKAWA-CHO
Manufacturer CityHACHIOJI-SHI, TOKYO-TO 192-8507
Manufacturer CountryJA
Manufacturer Postal192-8507
Manufacturer Phone426425177
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCYSTO-NEPHRO VIDEOSCOPE
Generic NameCYSTO-NEPHRO VIDEOSCOPE
Product CodeNWB
Date Received2018-06-25
Returned To Mfg2018-06-07
Model NumberCYF-VHA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerOLYMPUS MEDICAL SYSTEMS CORP.
Manufacturer Address2951 ISHIKAWA-CHO HACHIOJI-SHI, TOKYO-TO US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-25

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