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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 Mechanical Problem (1384); Difficult to Remove (1528)
Patient Problem Injury (2348)
Event Date 01/17/2019
Event Type  Injury  
Manufacturer Narrative

As part of our investigation, multiple follow up attempts were made via telephone and in writing to contact the user facility to obtain addition information regarding the patient, procedure and scope but no information has been obtained to date. The scope was returned to olympus but the evaluation is in progress. Olympus will continue to investigate the reported event. If additional information becomes available, this report will be updated accordingly.

 
Event Description

Olympus was informed that during a procedure, a scope became stuck inside the patient¿s urethra. The scope¿s insertion tube was in a 360 degree loop and the up lever worked but the down lever did not move the bending section tip of the scope. The physician had decided to cut the scope¿s insertion tube and had to rush the patient into surgery.

 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8324293
MDR Text Key135678199
Report Number2951238-2019-00429
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,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 01/24/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/20/2014
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: 02/08/2019 Patient Sequence Number: 1
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