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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problems Material Deformation (2976); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. The device was visually inspected and the user facility report was confirmed and found deep collapsed dent on the ring gauge. Additionally, the test results revealed chips, dents and exposed threads. The device was serviced and returned to the user facility.

 
Event Description

The use facility reported that the device was discovered to be packaged incorrectly when returned from reprocessing. It was reported that the scope appeared to have a kink and was in a permanent s shape. The user facility reported that the a non-reprocessed scope was used. No additional information was provided.

 
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Brand NameCYSTO-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 Key10228488
MDR Text Key199066737
Report Number8010047-2020-03858
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
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 08/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated By Manufacturer? Yes
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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