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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT
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OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT Back to Search Results
Model Number UHI-3
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2018
Event Type  malfunction  
Manufacturer Narrative
The subject uhi-3 has not been returned to olympus medical systems corp.(omsc) yet.Omsc will investigate the subject uhi-3 to identify the root cause of this failure phenomenon when omsc receives it.The uhi-3 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
On (b)(6) 2018, the subject uhi-3 suddenly increased the air pressure to the overpressure alarm during a uterus adnexectomy.The user restart the subject uhi-3 and the failure phenomenon was resolved.The user completed the intended procedure with the subject uhi-3.There was no report of the patient¿s injury regarding this event on (b)(6) 2018.The subject uhi-3 had been used until (b)(6) 2019.On (b)(6) 2019, the same failure, which the subject uhi-3 suddenly increased the air pressure, was occurred again.The user restart the subject uhi-3 but the failure still existed.The user suspended use of the subject uhi-3 and send to the olympus repair center.There was no report of the patient¿s injury regarding this event on (b)(6) 2019.
 
Manufacturer Narrative
The subject uhi-3 was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.However, the subject uhi-3 was returned to olympus local repair center for the repair.As an evaluation result of the subject uhi-3 by a local repair engineer, there was no abnormality found.The subject uhi-3 was returned to the user.And there has been no report that any failures occurred since the subject uhi-3 returned to the user.The device history record was reviewed and found no irregularities.Based on the evaluation result so far, omsc surmised that the reported failure phenomenon, which the subject uhi-3 suddenly increased the air pressure, was caused by another device/factor other than the subject uhi-3.
 
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Brand Name
HIGH FLOW INSUFFLATION UNIT
Type of Device
HIGH FLOW INSUFFLATION UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
MDR Report Key8585429
MDR Text Key144846578
Report Number8010047-2019-01870
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
PMA/PMN Number
K014166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUHI-3
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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