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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS CYSTO VIDEOSCOPE CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-240A
Device Problems Corroded (1131); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

Since the subject device was not returned to olympus medical systems corp. (omsc), it could not be investigated. Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity. The exact cause of the reported event could not be conclusively determined. Based on the report of the repair at the service department of olympus (b)(4), omsc surmised there was the possibility that it might be attributed to the deterioration due to the very long term-use passing 8 years since manufacturing the subject device. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that it was found the followings during the incoming inspection for the repair at the service department of olympus (b)(4). There was the foreign object on the light guide lens. There was the corrosion on the distal end. There was the corrosion inside the electrical connector due to water leakage. There was no patient injury associated with this report.

 
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Brand NameEVIS CYSTO 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 Key10337190
MDR Text Key200826999
Report Number8010047-2020-04952
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 07/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-240A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2012
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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