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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-VHR
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation. The definitive cause of the user's experience cannot be determined at this time. The investigation is ongoing. It is reported there is another device is possibly involved (cyf-vh) but we are not clear about the connection at this time. Additional information has been requested to clarify. This report will be updated upon completion of the investigation or upon receipt of additional relevant information. Cross-referenced importer's report number (b)(4).
 
Event Description
It is reported by a (b)(6) department of health physician, a patient experienced a urinary tract infection with the microorganism escherichia coli (e. Coli) within 15 days of a procedure with a videoscope cyf-v2. It is unknown how the infection was treated. No further consequences to the patient have been reported. The physician further states: we are not attributing the infections to improper reprocessing, only stating that patients had these organisms growing from urine on day 0-15 after the procedure. The incidence of infection does not appear to be outside of the range of ¿normal¿ and there is not a common organism that suggests the scope is persistently contaminated. Additional details have been requested regarding the patient and reported event. At this time, no further information has been provided. This event was reported as one of 4 related events. Case with patient identifier (b)(6) reports patient infection with enterobacter cloacae (e. Cloacae). Case with patient identifier (b)(6) reports patient infection with escherichia coli (e. Coli). Case with patient identifier (b)(6) reports patient infection with staphylococcus epidermidis (staph epi. ) case with patient identifier (b)(6) reports patient infection with pseudomonas aeruginosa (pseudomonas aer. ), and enterococcus faecalis (e. Faecalis).
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12356101
MDR Text Key268101934
Report Number8010047-2021-10635
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VHR
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 Received08/26/2021
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: 08/23/2021 Patient Sequence Number: 1
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