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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE

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AIZU OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VA2
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found that there was a angle operation failure.The angle is locked and cannot be released.A wire is broken and the end is stuck and the angle is stuck.Other evaluation findings include an insertion crease, forceps insertion failure, failure to insert cleaning brush with a crushed and scratched universal cord, scratched video cable and connector.There were scratches on the light guide connector with the label peeling off, scratches on video connector case.There were scratches on the control unit cover, switch box, grip, up/down angulation plate, on the angulation lever as well as the up/down angle fixing lever.The indicator on the grip has fallen off and there was corrosion on actuator, leakage of grip liquid, leakage of the up/down plate liquid and light guide bundle liquid leak.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus that the visera cysto-nephro videoscope is being returned for an angulation malfunction.The device was returned for evaluation.During the device evaluation, a reportable malfunction(s) was found: a broken wire causing the end to come apart and be immobilized.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the reported event is unable to be determined.Olympus will continue to monitor field performance for this device.
 
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Brand Name
VISERA CYSTO-NEPHRO VIDEOSCOPE
Type of Device
CYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18503865
MDR Text Key332988144
Report Number9610595-2024-00820
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170339455
UDI-Public04953170339455
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCYF-VA2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/12/2024
Supplement Dates Manufacturer Received02/08/2024
Supplement Dates FDA Received02/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2006
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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