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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II VIDEO SYSTEM CENTER Back to Search Results
Model Number CV-180
Device Problems No Display/Image (1183); Failure to Power Up (1476)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
During preparation for use, the user found that the video processor was turned on but not able to operate the front panel buttons. The user also found that the endoscopic image was not displayed. The patient was under anesthesia. The user replaced the device with another device and completed the procedure. There was no report of patient injury associated with this event. The user facility did not provide other detailed information.
 
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Brand NameEVIS EXERA II VIDEO SYSTEM CENTER
Type of DeviceVIDEO SYSTEM CENTER
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 Key12413218
MDR Text Key280744333
Report Number8010047-2021-11140
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCV-180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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