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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 Problem Difficult to Remove (1528)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 10/19/2020
Event Type  Malfunction  
Manufacturer Narrative

The device referenced in this report has been received by olympus, but has not yet been fully evaluated. The definitive cause of the customer's experience can not be determined at this time. This report will be updated upon completion of the investigation and if any relevant additional information is available.

 
Event Description

It is reported during a diagnostic cystoscopy using topical anesthetic (lidocaine gel) and a visera cysto-nephro videoscope, at the end of the procedure, the angulation on the scope became locked and would not disengage/straighten out and was stuck in the patient's urethra. The scope retroflexed at 180 degrees. There was urethral dilation that caused minor bleeding/mucosal tears requiring no treatment. There was no delay in the procedure and the planned procedure was completed using the complaint device. No additional consequences to the patient were reported. The scope was inspected prior to use and no damage or abnormalities were noted.

 
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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 Key10825092
MDR Text Key224686833
Report Number8010047-2020-08794
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/11/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/06/2011
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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