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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
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SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UCT260
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/21/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned for investigation.Upon evaluation, the reported issue was not confirmed.Should additional relevant information become available, a supplemental rep ort will be submitted.
 
Event Description
It was reported, the gastrovideoscope image was on and off.The issue occurred during preparation for use, prior to an echography operation.The same device was used to complete the operation and there were no reports of patient harm.
 
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Brand Name
EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
Type of Device
ULTRASOUND GASTROVIDEOSCOPE
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 Key18861646
MDR Text Key337593977
Report Number3002808148-2024-02170
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/07/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGF-UCT260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CV250SL
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