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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-VA2
Device Problem Device Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp.(omsc) was informed from the user when the field service engineer visited to the facility that the user had always cleaned the subject device using household detergent.The user had disinfected the subject device with olympus automated endoscope reprocessor oer-4 (not available in the usa).The occurrence date of the event is unknown.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The subject device was not returned to any of olympus locations.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.However, based on the reported information, omsc surmised that this phenomenon was attributed to the handling by the user.The instruction manual of the subject device stated the appropriate reprocess procedure.If additional information becomes available, this report will be supplemented.
 
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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 Key12251071
MDR Text Key280887119
Report Number8010047-2021-09549
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 health professional,user faci
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCYF-VA2
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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