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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VA2
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The subject cyf-va2 has not been returned to olympus medical systems corp.(omsc) for evaluation yet.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
 
Event Description
During the unspecified procedure with the cyf-va2, the bending section of the the subject device was deformed.The user cancelled the procedure.The nurse of the facility stated that the patient's anatomy made difficult to continue the procedure and also made the subject device deformed.There was no report of the patient injury other than above.
 
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Brand Name
VISERA 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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9731431
MDR Text Key221223020
Report Number8010047-2020-01460
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-VA2
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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