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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 Problems Inflammation (1932); Sepsis (2067)
Event Date 07/31/2019
Event Type  Injury  
Manufacturer Narrative

The subject device has not been returned to omsc for evaluation. As part of our investigation, the reprocessing practice of the user facility was checked, and there was no deviation. Omsc was informed that there were no fails or malfunctions on the subject device. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.

 
Event Description

Olympus medical systems corp. (omsc) was informed that 6 patients have experienced symptoms like inflammation and sepsis after procedures using the subject device. The date of the 6 procedures and the patients outcome attributed to the event are as follows; patient 1 underwent a procedure on (b)(6) 2018; urine specimen tested positive for enterococcus faecalis. Patient 2 underwent a procedure on (b)(6) 2019; no specimen test was conducted. Patient 3 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative. Patient 4 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative. Patient 5 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative. Patient 6 underwent a procedure on (b)(6) 2019; blood cultures and urine specimen tested negative. No microbe was detected from the sample collected from the subject device as a result of microbiological testing by the user facility. The patients were given additional treatment and became stable. This is 1 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
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key8943725
MDR Text Key155940382
Report Number8010047-2019-03118
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 10/29/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2019
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/29/2019 Patient Sequence Number: 1
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