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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-VHA
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed that during the incoming inspection for repair at olympus service operation repair center (sorc) on october 5, 2021, it was found that the angle was locked due to corrosion of the angle mechanism. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
Sorc checked the subject device and also found that the control section was damaged and had air leak. The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. The manufacturing record was reviewed and found no irregularities. The exact cause of the reported event could not be conclusively determined. Omsc presumed that moisture invaded the inside of the control section, and the angle operation failure occurred due to corrosion and rust of the internal parts.
 
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Brand NameCYSTO-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
MDR Report Key12716002
MDR Text Key281988269
Report Number8010047-2021-13777
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 company representative
Type of Report Initial
Report Date 10/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCYF-VHA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/05/2021
Is This a Reprocessed and Reused Single-Use Device? No

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