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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 Corroded (1131); Degraded (1153); Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation and repair. The evaluation confirmed the user report. There were worn out pins inside the video connector and corrosion on the picture-in-picture connector. The parts were replaced. This event is under investigation. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported there was static on the monitor when plugging in the camera for an evis exera ii video system center. This event was discovered during preparation for use. No patient involvement or impact to patient care was reported.
 
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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 Key11574572
MDR Text Key242445074
Report Number8010047-2021-04200
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2021
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 Manufacturer03/03/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2008
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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