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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 Problems Pin (906); Component Missing (2306)
Patient Problem Electric Shock (2554)
Event Date 07/03/2019
Event Type  Injury  
Manufacturer Narrative

The subject device has not been returned to omsc but was returned to keymed ltd. (okm). An electrical safety test was performed at okm in accordance with the olympus specification. The instrument failed the distal end insulation test, during the distal end insulation test minor electrical arcing was identified at the distal end. In addition, the following was confirmed; the locating pin of electrical connector of the subject device was missing. Water-resistant cap of the subject device was damaged. Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity. 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 a nurse felt an electric shock immediately after connecting the videoscope cable to the subject device before diagnostic procedure. The user facility completed the procedure using a similar device. The user facility noticed that a locating pin of electrical connector of the subject device was missing.

 
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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 Key8839796
MDR Text Key152620638
Report Number8010047-2019-02730
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 FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received07/04/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/24/2008
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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