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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-V2R
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 05/15/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and service.The evaluation confirmed that the device failed the leak test.Based on the visual inspection performed, the bending section cover was found torn at the middle section; no missing pieces.The distal end portion of the bending section was stretched over the tip.The large torn on the bending section cover caused the device to failed the air/water leakage test.The device was serviced and returned to the user facility.
 
Event Description
The user facility returned the device for evaluation and service due to the air/water leakage or fluid invasion issue.It was also reported that the bending section sheath of the bending section burst out, as the device was sterilized without attaching the safety cap.Olympus followed up with the user facility to obtain additional information and was informed that there was no patient involvement.No additional information was provided.
 
Event Description
Upon further review, 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.
 
Manufacturer Narrative
Upon further review, 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
VISERA 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 Key10153099
MDR Text Key223637094
Report Number8010047-2020-03338
Device Sequence Number1
Product Code FAJ
UDI-Device Identifier04953170287619
UDI-Public04953170287619
Combination Product (y/n)N
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-V2R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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