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U.S. Department of Health and Human Services

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

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SHIRAKAWA OLYMPUS CO., LTD. VISERA CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-V2
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/13/2023
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and customer's allegation was confirmed.Additionally, the evaluation found the following: the bending section cover was torn, and testing was unable to be performed due to the torn bending section cover.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 videoscope had defects of the distal end and adhesive, it was sterilized without the pressure cap and the distal tip needed to be recoated.The issue was found during reprocessing.There were no reports of patient harm.
 
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, a definitive root cause of the reported device sterilization without the pressure cap issue could not be determined, however, the issue was likely due to user mishandling/error.The event may be detected by following the instructions for use section below: instructions visera cysto-nephro videoscope olympus ltd type v2 olympus ltd type va2 olympus ltd type v2r chapter 5 reprocessing: general policy chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures 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)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18246732
MDR Text Key330566572
Report Number3002808148-2023-13563
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170339431
UDI-Public04953170339431
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K221683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/27/2023
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 Health Professional
Device Model NumberCYF-V2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/13/2023
Initial Date FDA Received12/01/2023
Supplement Dates Manufacturer Received12/11/2023
Supplement Dates FDA Received12/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/06/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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