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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-V2R
Device Problem Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Device was received for evaluation. Evaluation determined that the device was found with a torn ¿a-rubber¿. Leak testing was unable to be performed due to blown ¿a-rubber¿ unit. The rubber glue was observed to be a non-olympus unit along with insertion tube, lg (light guide) tube both units were determined to be a non-olympus. A missing ring was found on the control body and a cracked m-case was observed on the video connector. The identified parts needs to be replaced. Device was placed for repair. Based on evaluation findings, the reported issue was confirmed. The root cause of the issue were attributed to users handling, maintenance issue.

 
Event Description

It was reported that device was found with exploded sheath. The issue occurred during a reprocessing. There was no patient involvement on this report. No user harm or injury reported.

 
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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 Key10653151
MDR Text Key223662728
Report Number8010047-2020-07430
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/24/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/05/2012
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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