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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 Problem Microbial Contamination of Device (2303)
Patient Problems Unspecified Infection (1930); Urinary Tract Infection (2120)
Event Date 12/20/2019
Event Type  Injury  
Event Description

The service center was informed of a reported patient infection as the infection prevention and control manager stated the facility was investigating two patients who acquired urinary tract infections and blood stream infections with the same organism post cystoscopy procedure for stent removal. Different scopes were used for each procedure. The facility has observed the procedure in the clinic setting and did not observe any practice or infection control concerns. The scopes have been sent to the manufacturer's service center for evaluation of the scopes to ensure integrity. As part of our investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facilities reprocessing practice and to provide a reprocessing training. To date, the ess visit has not been finalized. The scope was returned and was forwarded to an independent laboratory for microbial testing. If additional information becomes available, this report will be supplemented accordingly. This is for 2 of 2 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
MDR Report Key9975521
MDR Text Key188243455
Report Number2951238-2020-00428
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/20/2020,04/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/24/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/20/2020
Device Age1 yr
Event Location Hospital
Date Report TO Manufacturer03/20/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/17/2020 Patient Sequence Number: 1
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