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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 Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus and the customer's allegation was not confirmed.The problem could not be reproduced.Additional information has been requested regarding this event.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The distributor reported to olympus, the high flow insufflation unit was unable to inflate temporarily.There were no reports of patient harm associated with this event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information obtained from 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.The investigation did not establish a root cause for the reported device problem.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 Key16155710
MDR Text Key309033896
Report Number3002808148-2023-00377
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170140297
UDI-Public04953170140297
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Manufacturer12/14/2022
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received01/13/2023
Supplement Dates Manufacturer Received01/09/2023
Supplement Dates FDA Received02/07/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/21/2017
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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