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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problems Fluid Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

No additional information of the event is available yet. Event date is unknown. Device was returned and evaluated. User complaint was confirmed. The device failed leak test due to leak from bending cover and insertion tube. A hole was found on insertion tube and c-cover was detached. The device passed all other checks. Conclusion based on device evaluation is that there is physical damage to the device from causes not known.

 
Event Description

As reported for this event, during reprocessing a leak was observed from the distal end tip.

 
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Brand NameCYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9950238
MDR Text Key222559912
Report Number8010047-2020-02136
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/15/2020
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

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