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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 Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/22/2016
Event Type  malfunction  
Manufacturer Narrative
The subject device and concomitant the ltf-s190-10 were returned to olympus for evaluation. Olympus confirmed the subject device worked properly. Olympus could reproduce the phenomenon when the subject device was connected to the ltf-s190-10. The subject device detected ccd over current when the ltf-s190-10 was connected to the subject device. Therefore, the ltf-s190-10 might have some malfunctions. Olympus also checked the device history record of the subject device, and there was no irregularity found. There were no further details provided at this time. If significant additional information is received, this report will be supplemented. Please cross reference the associated complaint files: mfr report#: 8010047-2016-00231.
 
Event Description
The monitor image was lost when the user facility inserted the endoeye flex deflectable videoscope ltf-s190-10 to the patient's body cavity. The user facility turned off and on the subject device, and disconnected and connected the video connector to the subject device. However, the phenomenon still occurred. The facility completed the procedure with replacing the videoscope to another videoscope. 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 Key5455849
MDR Text Key38856691
Report Number8010047-2016-00210
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 02/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
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 Manufacturer02/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/23/2016 Patient Sequence Number: 1
Treatment
LTF-S190-10
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