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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Peeled/Delaminated (1454)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

There is no additional information available for this event as yet. Event date is not known, the month and the year is january 2021. The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time. Supplemental report(s) will be filed as the information becomes available.

 
Event Description

As reported for this event, during reprocessing the device rubber cover at the distal end was peeling off. There is no patient involvement and no harm reported to any patient.

 
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Brand NameVISERA CYSTO-NEPHRO 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 Key11337177
MDR Text Key232160577
Report Number8010047-2021-02745
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 04/05/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/17/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/27/2021
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/23/2012
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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