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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. CYSTO-NEPHRO VIDEOSCOPE Back to Search Results
Model Number CYF-VH
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.During the evaluation, the scope did not pass the leak test.The reported issue was confirmed, the insertion tube sheath was damaged exposing the metal mesh.The light guide tube had minor dents and scratches.No other issues were found during the inspection.If additional information is provided a supplemental report will be filed.
 
Event Description
A user facility reported a videoscope with a broken bending rubber and the metal sticking out close to where the cord is located.The issue was found during reprocessing of the device.There was no patient involvement or injuries.No additional information has been obtained.
 
Manufacturer Narrative
Upon further review of the reported issue, it was determined that this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
CYSTO-NEPHRO VIDEOSCOPE
Type of Device
CYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10718401
MDR Text Key213025223
Report Number8010047-2020-08003
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
PMA/PMN Number
K062049
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-VH
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Was the Report Sent to FDA? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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