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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-VH
Device Problems Microbial Contamination of Device (2303); Material Integrity Problem (2978)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative

The device was not returned to the service center for evaluation. The user facility did not provide a specific serial number for the subject; therefore, no review of the instrument history can be performed. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported events. If additional information becomes available, this report will be updated and supplemented accordingly. The cyf-vh ¿reprocessing before the first use/reprocessing and storage after use¿ section of the instruction manual warns users after using this instrument, reprocess and store it according to the instructions given in the endoscope¿s companion reprocessing manual. Improper and/or incomplete reprocessing or storage can pose an infection control risk, cause equipment damage, or reduce performance. ¿.

 
Event Description

The service was informed that six patients contracted salmonella infections in their bladder after undergoing cystoscopy procedures with the facility¿s cysto-nephro videoscope. The user facility¿s physician reported that this has led to sepsis in some of the patients. The bacteria has been tested and found to be the same genetic bug in each case. The user facility has identified 35 additional patients that will need to be notified as they also were in contact the subject scope. All patients were seen at the same clinic. In addition, the physician reported that the scope passed the leak test and appeared in satisfactory condition upon quick visual inspection. The facility performed a closer visual inspection on the subject scope and observed break, separation or perforation along the insertion tube of the scope; where the uppermost point of the bending rubber begins and meets the bending section bending rubber. The scope was then cultured and tested positive for salmonella. This is 5 of 6 reports.

 
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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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8701939
MDR Text Key148200307
Report Number2951238-2019-00944
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,Followup,Followup,Followup
Report Date 05/15/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/10/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2020
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

Patient TREATMENT DATA
Date Received: 06/14/2019 Patient Sequence Number: 1
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