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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Fever (1858)
Event Date 10/18/2019
Event Type  Injury  
Event Description

The manufacturer was informed that 24 hours after a cystoscopy procedure, the patient had a fever and needed to be hospitalized. The patient's urine culture indicated that the patient contracted pseudomonas aeruginosa >100,000 cfu/ml. The patient's urine culture on (b)(6) 2019 and prior to the procedure indicated that everything was normal. The facility utilizes aldahol for reprocessing and the aldahol's efficacy is tested daily.

 
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Brand NameVISERA CYSTO-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 Key9334737
MDR Text Key166779781
Report Number2951238-2019-01190
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
Type of Report Initial
Report Date 10/24/2019,11/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/24/2019
Event Location Outpatient DIAGNOSTIC Facility
Date Report TO Manufacturer10/24/2019
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: 11/18/2019 Patient Sequence Number: 1
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