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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 Fluid Leak (1250); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. The device was tested and visually inspected, results identified a leak/cut during leak testing and minor dents and scratches were observed from visual inspection. Visual inspection also revealed bending section of the device was detaching and adhesive presented cracks likely due to physical damage. The device was serviced and returned to the user facility.

 
Event Description

The customer reported that a loose joint was noticed during a procedure by the surgeon. The customer reported there was no patient harm. It was reported that the surgeon completed the case with the same device without any delay in procedure.

 
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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 Key10141248
MDR Text Key194887845
Report Number8010047-2020-03257
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 09/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/10/2020
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 Manufacturer05/13/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/10/2020
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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