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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 Problem Unspecified Infection (1930)
Event Date 06/21/2019
Event Type  Injury  
Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that five patients were infected with proteus mirabilis after cystoscopy using the subject device. The procedure date of the five patients were as follows; first patient: (b)(6) 2019, second patient: (b)(6) 2019, third patient: (b)(6) 2019, forth patient: (b)(6) 2019, fifth patient: (b)(6) 2019. The five patients were treated with antibiotics. It was reported that the subject device had been reprocessed by the user facility as following procedures; the leakage test was performed on the subject device, and subject device was rinsed with water and wiped off. The subject device was immersed in a non-olympus detergent solution (deconex 53 plus, borer chemie ag) for 15 minutes, and cleaned using an olympus channel cleaning brush (bw-15b) and channel-opening cleaning brush (mh-507). The subject device was flushed using a non-olympus syringe (deconex, borer chemie ag). The subject device was rinsed with water. The subject device was immersed in a non-olympus disinfectant solution (deconex hld pa20, borer chemie ag) for 3 minutes, and flushed using a non-olympus syringe (deconex, borer chemie ag). The subject device was rinsed with a non-olympus alcohol (aquadest). The subject device was dried using an air blower. The user facility conducted microbiological culturing testing on subject device. In the testing, the sample collected from the subject device tested positive for proteus mirabilis (the number of microbe is unknown). Omsc is submitting five medical device reports according to the number of the infected patients. This is one of five 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 Key9080377
MDR Text Key161965243
Report Number8010047-2019-03307
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeSZ
PMA/PMN NumberK062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/06/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberCYF-VH
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/18/2019 Patient Sequence Number: 1
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