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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 Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/22/2017
Event Type  Malfunction  
Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation. Omsc reviewed the manufacturing history of this device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that the image of the subject device disappeared during diagnostic procedure. The user facility completed the intended procedure by exchanging the device. There was no patient injury associated with this report.

 
Manufacturer Narrative

This supplemental report is being submitted to provide the subject device additional informations. The subject device has not been returned to olympus medical systems corp. (omsc) but was returned to olympus europa k. G (oekg). As a result of this device confirmation by oekg, the reported image loss was not duplicated. However, oekg found that the marks of humidity invasion were found inside the video connector. In addition, the heavy kinked were confirmed on the insertion tube. From the above, there is a possibility that due to the humidity entering in the video connector, the circuit of the electric board in the video connector was short-circuited and image disappearance occurred, but the exact cause of the reported event could not be conclusively determined.

 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key7188812
MDR Text Key97868204
Report Number8010047-2018-00046
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
OTHER Device ID Number04953170310461
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/16/2017
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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