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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative

The scope was returned and was forwarded to an independent laboratory for microbial testing. 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. If additional information becomes available, this report will be supplemented accordingly. This event has been reported by the importer on mdr # 2951238-2020-00427.

 
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 cysto 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. This is for 1 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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9975527
MDR Text Key195577769
Report Number8010047-2020-02257
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 05/18/2020
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
Event Location No Information
Date Manufacturer Received04/22/2020
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: 04/17/2020 Patient Sequence Number: 1
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