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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-240
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2020
Event Type  Malfunction  
Manufacturer Narrative

The subject device in this report was not returned to omsc for evaluation. 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

Olympus medical systems corp. (omsc) was informed that during an unspecified procedure with the subject device at the user facility, it was found the instrument channel port of the subject device had been loosened. The user facility completed the procedure using the subject device with no delay. There was no report of patient injury associated with this event. The user facility did not provide other detailed information. Olympus (b)(4) checked the subject device and found that the instrument channel port of the subject device was loose and leaked.

 
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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 Key10578378
MDR Text Key208321846
Report Number8010047-2020-06818
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-240
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 Received10/23/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/15/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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