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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 Problem Fluid Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to olympus for evaluation. During the evaluation the device failed the leak test due to a cut on the insertion tube. A deep scratch was found on the plastic and peeled glue around the objective lens. The bending section of the scope was detached from the body. The customer received a loaner device while the scope was being serviced. No other issues or injuries have been reported. If any additional information is obtained a follow up report will be filed.

 
Event Description

A user facility reported that a surgical scope failed the leak test during reprocessing. No patient involvement was reported. No additional information has been obtained.

 
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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 Key10370317
MDR Text Key202102772
Report Number8010047-2020-05302
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 USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/08/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/31/2015
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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