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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 Excess Flow or Over-Infusion (1311)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2024
Event Type  malfunction  
Event Description
It was reported the insufflation unit exhibited excessive pressure alarm.The issue occurred during a therapeutic laparoscopy procedure.The intended procedure was completed using the same set of equipment.There were no reports of delays.There were no reports of patient harm.
 
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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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 Key18987671
MDR Text Key338724460
Report Number3002808148-2024-02917
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2024
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2024
Initial Date FDA Received03/27/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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