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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT
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SHIRAKAWA OLYMPUS CO., LTD. HIGH FLOW INSUFFLATION UNIT Back to Search Results
Model Number UHI-3
Device Problem Pressure Problem (3012)
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 that the high flow insufflation unit was not producing enough pressure.The issue occurred during a bariatric procedure.The intended procedure was completed successfully using a similar device.There were no reports of patient harm.
 
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Brand Name
HIGH FLOW INSUFFLATION UNIT
Type of Device
HIGH FLOW INSUFFLATION UNIT
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 Key19209292
MDR Text Key341931792
Report Number3002808148-2024-03989
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170140297
UDI-Public04953170140297
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K014166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUHI-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/16/2004
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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