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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VA2
Device Problems Device Reprocessing Problem (1091); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

There is no additional information for this event as yet. The event date is not known. Supplemental report(s) will be filed as the information becomes available. The device has been returned and a device evaluation completed for it. The user¿s complaint was confirmed. Upon inspection, the a-rubber of the bending section was observed to be torn. This is attributed to the user¿s incorrect reprocessing. The bending section within was dry with no frayed wires. No other issues were noted for the device.

 
Event Description

As reported for this event, during reprocessing the device was damaged as the device was reprocessed in the v-pro with no gas cap. There is no patient involvement.

 
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Brand NameVIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSION
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 Key10260878
MDR Text Key223652759
Report Number8010047-2020-04167
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-VA2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/23/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/24/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2013
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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