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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 Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2015
Event Type  Malfunction  
Manufacturer Narrative

The subject device is not returned to olympus yet. Olympus will investigate the subject device to determine the cause of this phenomenon after olympus receives it. Olympus is under investigation for the cause of this phenomenon. Olympus will submit a supplemental mdr report after the cause of this phenomenon is determined. This report is being submitted as a medical device report in an abundance of caution.

 
Event Description

Olympus was informed that during cholecystectomy, a monitor image disappeared when the facility outputted the electric knife. The facility completed the procedure to replace a device to their spare device but there was no information what device the facility replaced. 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
kunimori yamaguchi
2951 ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
42 6425177
MDR Report Key5080101
MDR Text Key26310381
Report Number8010047-2015-00914
Device Sequence Number1
Product Code LLZ
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK954451
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 08/19/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2015
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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