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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-VHR
Device Problems No Display/Image (1183); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Device was received and evaluated.Evaluation determined that the device was found with leaks and black image.Bending section was found detached and insertion tube was observed with dents.In addition, ¿a-rubber glue¿ was found with a crack.The device was placed for repair.Based on evaluation findings, the reported failure was confirmed.Failure likely attributed to users handling and or maintenance issue.
 
Event Description
It was reported that the device exhibited loss of id scope no image, it would not connect correctly.The issue occurred during preparation for use.There was no patient involvement on this report.No user injury reported.
 
Manufacturer Narrative
This supplemental report is to advise that upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
CYSTO-NEPHRO VIDEOSCOPE
Type of Device
CYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10919799
MDR Text Key218983939
Report Number8010047-2020-09605
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-VHR
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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