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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 Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to sorc but has not been returned to omsc. Sorc checked the subject device for evaluation. It was confirmed that the angulation of the subject device became locked and could not disengaged due to the deterioration of the angulation mechanism by the rust. The exact cause of the reported event could not be conclusively determined at this time. If additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc), it was found that the angulation of the subject device became locked and could not disengaged. The occurrence date of the event is unknown. There was no report of patient injury associated with the event.
 
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Brand NameVISERA CYSTO-NEPHRO VIDEOSCOPE
Type of DeviceCYSTO-NEPHRO VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12322322
MDR Text Key267087313
Report Number8010047-2021-10242
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCYF-VA2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/12/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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