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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE; ULTRASOUND GASTROVIDEOSCOPE
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SHIRAKAWA OLYMPUS CO., LTD. EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE; ULTRASOUND GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UE290
Device Problem No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Event Description
It was reported, the ultrasound gastrovideoscope displayed error us9a08 when gf-ue290/eu-mer was connected and no ultrasound image appeared.The issue occurred during preparation for a diagnostic procedure that was completed using a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE
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 Key18952316
MDR Text Key339104588
Report Number3002808148-2024-02710
Device Sequence Number1
Product Code ODG
Combination Product (y/n)N
Reporter Country CodeJA
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 03/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGF-UE290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/04/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/10/2020
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
EU-ME2-EVIS EUS ENDOSCOPIC ULTRASOUND CENTER.
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