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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-4
Device Problem Gas/Air Leak (2946)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2024
Event Type  malfunction  
Event Description
It was reported, during preparation for use in an unspecified procedure, the insufflator was leaking from the inside.The procedure was completed without delay.There were no other devices involved.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned and the evaluation confirmed the electropneumatic proportional valve was leaking.Additionally the error codes e03 and e04 were observed in the error logs due to a printed circuit board failure.Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 9 years since the subject device was manufactured.Based on the results of the investigation, the reported event (leak around electro-pneumatic proportional valve) was likely due to damage to the electro-pneumatic proportional valve unit.In addition, the errors (e03 and e04) likely occurred due to a problem with the circuit (cr) board.However, the root cause of the failures could not be determined.This supplemental report includes a correction to g2 and e1 from the initial medwatch.Olympus will continue to monitor field performance for this device.
 
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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
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18852623
MDR Text Key337796121
Report Number3002808148-2024-02111
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public04953170324147
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUHI-4
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2024
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/19/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/20/2014
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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