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U.S. Department of Health and Human Services

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

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OLYMPUS MEDICAL SYSTEMS COOPERATION VISERA VIDEO SYSTEM CENTER VIDEO PROCESSOR Back to Search Results
Model Number OTV-S7V
Device Problem Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2015
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned to olympus for evaluation. The reported phenomenon was reproduced when olympus jiggled the video connector plug of a camera head up and down with connecting a camera head to the subject device. The subject device worked properly with replacing the video connector socket to another one. There was corrosion on the electrical contact of the video connector socket. The user facility might connect the subject device with a camera head whose electrical contact of the video plug was not dry after the camera head was reprocessed. Therefore, the electrical contact of the video connector socket might get corroded, resulting in contact failure between the subject device and the camera head. 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 make sure the video plug and its electrical contacts of a camera head are completely dry before connecting the plug to 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
The user facility informed olympus that an abnormal monitor image occurred with using the subject device on (b)(6) 2015. Olympus asked the user facility about the detailed situation when the phenomenon occurred, and obtained following additional information on february 19, 2016. During hysteroscopy, an abnormal monitor image occurred when the user facility turned on the subject device after the patient was anesthetized. The user facility aborted the procedure because of this phenomenon. There was no report of patient injury.
 
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Brand NameVISERA 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 Key5490745
MDR Text Key40024423
Report Number8010047-2016-00347
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K083155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 03/10/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOTV-S7V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/24/2012
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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