Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT Back to Search Results
Model Number UHI-4
Device Problems Defective Alarm (1014); No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.A full technical evaluation was completed in accordance with the olympus' specification.The insufflator was tested: after starting up it went into alarm mode (alarm sound occurred) and no indicators were lighted on front panel.It was identified that all these phenomena were related to a failure of the cr board.Additionally, it was also noticed that the alarm generated during testing indicated a decrease in the remaining amount of co2 in the cylinder.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported to olympus that during abdominal surgery procedure, the high flow insufflation unit alarm sounded with no image displayed on the screen.The device was reset, and the procedure was completed with the same device.There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
The device was returned to olympus for evaluation.A full technical evaluation was completed in accordance with the olympus' specification.The insufflator was tested: after starting up it went into alarm mode (alarm sound occurred) and no indicators were lighted on front panel.It was identified that all these phenomena were related to a failure of the cr board.Additionally, it was also noticed that the alarm generated during testing indicated a decrease in the remaining amount of co2 in the cylinder.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported to olympus that during abdominal surgery procedure, the high flow insufflation unit alarm sounded with no image displayed on the screen.The device was reset, and the procedure was completed with the same device.There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Based on the results of the investigation: - there is a possibility that the display went off due to the failure of the circuit board, but the cause of the failure of the circuit board could not be determined.- an alarm may have gone off because the remaining amount of co2 in the cylinder decreased, but it was not possible to determine the cause of the decrease in the amount of co2 remaining in the cylinder.Olympus will continue to monitor field performance for this device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key13502396
MDR Text Key285418359
Report Number8010047-2022-02705
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public04953170324147
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K122180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
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 Manufacturer01/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/04/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-