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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-VHR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Patient Problem/Medical Problem (2688)
Event Type  Injury  
Manufacturer Narrative

The device referenced in this case was not returned to olympus for physical evaluation. An olympus field representative compared the complaint scope to another manufacturer's scope in the field and noted that the insertion tube outer diameter of the olympus scope is 0. 5mm bigger than other manufacturer's cystoscope and the distal end of the olympus scope is smaller (8. 1fr) compared to the other manufacturer's scope (10. 9fr). Additional information regarding the patients/event is being pursued. At the time additional relevant details becomes available and/or at completion of the investigation, this report will be updated accordingly.

 
Event Description

It is reported that two physicians have mentioned that the olympus cysto-nephro videoscope is bigger than another manufacturer's scope making it more traumatic to navigate in patients with urethral stenosis, and this lead to increased bleeding and tearing in a couple of cases. No additional information is available at this time. There was no report of any device malfunction.

 
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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 Key10747664
MDR Text Key213428451
Report Number8010047-2020-08222
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/28/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VHR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 10/28/2020 Patient Sequence Number: 1
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