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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS OLYMPUS CYSTO-NEPHRO VIDEOSCOPE (VISERA) CYSTOSCOPE

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OLYMPUS OLYMPUS CYSTO-NEPHRO VIDEOSCOPE (VISERA) CYSTOSCOPE Back to Search Results
Model Number CYF-V2R
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/05/2017
Event Type  No Answer Provided  
Event Description

Pt underwent a cystoscopy. During procedure, the provider noticed a substance in the bladder coming from the scope that appeared to float in the bladder. The pt's bladder was drained and it was noted that there appeared to be an oil emulsion floating on the urine.

 
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Brand NameOLYMPUS CYSTO-NEPHRO VIDEOSCOPE (VISERA)
Type of DeviceCYSTOSCOPE
Manufacturer (Section D)
OLYMPUS
center valley PA
MDR Report Key6743778
MDR Text Key81186187
Report NumberMW5071244
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 Voluntary
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 06/07/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/25/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberCYF-V2R
Device LOT NumberUPC CODE:N3827630
Was Device Available For Evaluation? Device Returned To Manufacturer
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 07/25/2017 Patient Sequence Number: 1
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