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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-VA2
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 07/13/2017
Event Type  Injury  
Manufacturer Narrative
This device referenced in this report has been returned to olympus medical systems corp. For evaluation. During the evaluation, it was confirmed that the insertion tube was kinked, and no other anomaly was found. The exact cause could not be conclusively determined.
 
Manufacturer Narrative
This supplemental report is submitting to correct "device product code" and "pma/510(k) number".
 
Manufacturer Narrative
This device referenced in this report has been returned to olympus medical systems corp. For repair and it is under evaluation. The service record does not state that there are scratches on the wall of the channels of the subject device. At the user facility, there were 4 patients infection with pseudomonas having undergone a cystoscopy with cyf-va2 from (b)(6) in 2016. Please refer to the mdr's: #8010047-2016-01229, #8010047-2016-01230, #8010047-2016-01231 and #8010047-2016-01232. The subject device has been reportedly cleaned and disinfected after procedures, and sometimes sterilized. The manufacturing record of the device was reviewed without irregularity related to this event. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available at a later time, this report will be supplemented.
 
Event Description
Olympus was informed that a hospitalized patient having undergone a cystoscopy was infected with pseudomonas after several days from the procedure. Symptoms and outcomes of the patient are unknown. The user facility is investigating if there is any patient who has symptoms of infection because the subject device has been used for other outpatient(s). As the infection source has not been identified, the user is reportedly investigating not only the subject device but other infection source.
 
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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
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6772985
MDR Text Key113060852
Report Number8010047-2017-01185
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCYF-VA2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2006
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: 08/07/2017 Patient Sequence Number: 1
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