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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 Problems Break (1069); Device Reprocessing Problem (1091)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

The device was received by olympus evaluation. The user facility report was confirmed and found leaking at a rubber glue and damage on the scope. Additional information provided by the reporter on (b)(6) 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope. The device has been serviced and returned to the user facility. Olympus will continue to monitor complaints for this device.

 
Event Description

The user facility reported that the distal end of the scope is broken. Additional information provided by the reporter on august, 7 2020 confirmed that the sterile processing team at the facility did not put the valve back on the scope during reprocessing which may have led to the defect of the scope. The reporter indicated that corrective actions have been taken on site with training to ensure this doesn't happen in the future. No additional information was provided.

 
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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 Key10381354
MDR Text Key202187008
Report Number8010047-2020-05388
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
Report Date 08/07/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/07/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/09/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/09/2020
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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