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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA ELITE VIDEO SYSTEM CENTER OTV-S190 VIDEO PROCESSOR

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OLYMPUS MEDICAL SYSTEMS CORPORATION VISERA ELITE VIDEO SYSTEM CENTER OTV-S190 VIDEO PROCESSOR Back to Search Results
Model Number OTV-S190
Device Problem Image Display Error/Artifact (1304)
Patient Problems No Consequences Or Impact To Patient (2199); Hernia (2240)
Event Date 04/17/2015
Event Type  Malfunction  
Event Description

Olympus was informed that noise on the monitor screen occurred during laparoscopic hernia restoration. The facility replaced the subject otv-s190 to another system to complete the procedure. There was no injury report of this event except exchanging the device.

 
Manufacturer Narrative

The subject otv-s190 was returned to olympus for eval. Olympus could not confirm the phenomenon but there were foreign substances near the electrical contact of the video connector socket. Olympus could reproduce this phenomenon by connecting a scope to the otv-s190, placing foreign substances on the scope connector pins for insulation. This phenomenon might be attributed to conduction failure between the scope and the otv-s190 because adhesion of foreign substances inside the video connector socket or water on the scope connector might interrupt connection between the two devices temporarily. Olympus also checked the mfg history of the subject device, and there was no irregularity found. The instructions manual already stated notifications of electrical contact handling. This report is being submitted as a medical device report in an abundance of caution.

 
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Brand NameVISERA ELITE VIDEO SYSTEM CENTER OTV-S190
Type of DeviceVIDEO PROCESSOR
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORPORATION
2951 ishikawa-cho
hachioji-shi 195- 8507
JA 195-8507
Manufacturer Contact
susumu nishina
2951 ishikawa-cho
hachioji-shi 192-8-507
JA   192-8507
26425177
MDR Report Key4812373
MDR Text Key5917754
Report Number8010047-2015-00371
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 04/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/27/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberOTV-S190
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/13/2015
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/27/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2013
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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