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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION VISERA ELITE VIDEO SYSTEM CENTER VIDEO PROCESSOR

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OLYMPUS MEDICAL SYSTEMS COOPERATION VISERA ELITE VIDEO SYSTEM CENTER VIDEO PROCESSOR Back to Search Results
Model Number OTV-S190
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2016
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus for evaluation. Olympus confirmed the videoscope locking mechanism of the video connector broke and a videoscope was connected to the subject device unstably. The user facility might disconnect a videoscope from the subject device without pressing the locking lever. Therefore, the spring which could keep the videoscope connection locked broke and the videoscope could not connect the subject device firmly. Olympus also checked the device history record of the subject device, and there was no irregularity found. The instruction manual of this device already mentions that an operator should push the locking lever down to disconnect the video plug of the videoscope from this device. There were no further details provided. If significant additional information is received, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution.
 
Event Description
When the patient underwent general anesthesia during unspecified procedure, the user facility found a videoscope image on the monitor became dark even though menu display was shown on the monitor properly. The user facility replaced the videoscope to another videoscope, but the phenomenon still occurred. After that, the user facility replaced the subject device to another device and the phenomenon did not occur. The user facility completed the procedure using the replaced device. There was no report of patient injury in this event.
 
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Brand NameVISERA ELITE VIDEO SYSTEM CENTER
Type of DeviceVIDEO PROCESSOR
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS COOPERATION
2951 ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
42 6425177
MDR Report Key5440266
MDR Text Key38286712
Report Number8010047-2016-00285
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K954451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 02/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOTV-S190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/25/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/04/2013
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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