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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 07/04/2019
Event Type  Injury  
Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation because the user facility continues to use the subject device. 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 a patient was infected with urosepsis after cystoscopy using the subject device. The patient underwent cystoscopy and transrectal ultrasound-guided prostate biopsy on (b)(6) 2019, and was discharged from the user facility on the day. The patient visited the user facility again on (b)(6) 2019, and treatment for urosepsis was commenced. After that, the patient was then transferred to another user facility and treated with intravenous antibiotics and oral antibiotics. The patient was discharged from this user facility several days later. Other detailed information such as the reprocessing method was not provided. The user facility continues to use the subject device because no other infection was reported. The user facility mentioned that they believe that the subject device was not the cause of the patient infection.

 
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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 Key8924937
MDR Text Key155323298
Report Number8010047-2019-03023
Device Sequence Number1
Product Code FAJ
Combination Product (Y/N)N
Reporter Country CodeUK
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
Report Date 10/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2019
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/19/2018
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: 08/23/2019 Patient Sequence Number: 1
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