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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 Loss of Power (1475)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2024
Event Type  malfunction  
Manufacturer Narrative
E1 establishment address: (b)(6).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported the high flow insufflation unit gave an error before the front display turned off after selecting the cavity to be used for an exam.The issue occurred during preparation for use in an unidentified procedure.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 Key19164644
MDR Text Key341513919
Report Number3002808148-2024-03763
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public04953170324147
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/23/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2024
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 Manufacturer04/15/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
ESG-400 ELECTROSURGICAL HF GENERATOR; OTV-S200 SURGICAL IMAGING SYSTEM
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