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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
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SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE Back to Search Results
Model Number GF-UCT180
Device Problem Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the evis exera ii ultrasound gastrovideoscope exhibited foreign material on the knob wire.There were no reports of patient involvement.
 
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 EXERA II 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 Key18960275
MDR Text Key338771904
Report Number3002808148-2024-02756
Device Sequence Number1
Product Code ODG
UDI-Device Identifier04953170356339
UDI-Public04953170356339
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K093395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
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 Other
Device Model NumberGF-UCT180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2024
Was Device Evaluated by Manufacturer? No
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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