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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 12/22/2023
Event Type  malfunction  
Event Description
It was reported, the high flow insufflation unit had a leak in the gas regulator.The issue was identified during the reprocessing process, after a diagnostic (laparoscopic cholecystectomy) procedure.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned to olympus for evaluation and the investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
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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 Key18658421
MDR Text Key334885325
Report Number3002808148-2024-01168
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2024
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 Manufacturer01/27/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/06/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2019
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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