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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 Break (1069)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.The user¿s complaint was confirmed.The device was visually inspected and found the a-rubber was blown off/torn.There were no leaks detected in the a-rubber.The insertion tube has a tiny white line that is peeling.There was a thin non-leaking crack on the side of the pc board.No additional information was provided.
 
Event Description
The user facility reported that the distal end of the scope was broken and exposed.There was no patient involvement.No additional information was provided.
 
Manufacturer Narrative
The device was returned because the distal end of the scope was broken and exposed there is more information on the device evaluation.This supplemental report is being submitted to provide this information.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.There is no repair history for the device.The likely cause of the tip damage is because some external force was applied to the device.The instructions for use includes the following statements in chapter 6 compatible reprocessing methods and chemical agents: attach the sterilization cap to the endoscope before ethylene oxide gas sterilization.If the sterilization cap is not attached to the endoscope during ethylene oxide gas sterilization, the air inside the endoscope will expand and could rupture the bending section cover and/or damage the angulation mechanism (see figure 6.2).Exceeding the recommended parameters may cause equipment damage.Do not exceed the parameters outlined in tables 6.3 and 6.4 on page 63.Do not seal the endoscope with other equipment that may contact the endoscope in the package.Otherwise, the endoscope may be damaged.
 
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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 Key10385004
MDR Text Key202207458
Report Number8010047-2020-05408
Device Sequence Number1
Product Code FAJ
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 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2020
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 Manufacturer07/14/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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