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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE VIDEO SYSTEM CENTER
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SHIRAKAWA OLYMPUS CO., LTD. VISERA ELITE VIDEO SYSTEM CENTER Back to Search Results
Model Number OTV-S190
Device Problem Erratic or Intermittent Display (1182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the video system center had image failure.There were no reports of patient harm.
 
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Brand Name
VISERA ELITE VIDEO SYSTEM CENTER
Type of Device
VIDEO SYSTEM CENTER
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18961100
MDR Text Key338380326
Report Number3002808148-2024-02764
Device Sequence Number1
Product Code FET
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/17/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/17/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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