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 Excess Flow or Over-Infusion (1311); Free or Unrestricted Flow (2945); Fail-Safe Did Not Operate (4046)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Oxygen Saturation (2477); Abdominal Distention (2601)
Event Date 01/02/2022
Event Type  Injury  
Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center could not confirm any problem with functionality.The device is without any sign of damage.It is very likely that the described problem is caused by a faulty main board where there are pressure sensor circuits and control circuits placed.It is a serious issue and due to this it is recommend to replace the main board to avoid further malfunction.The device meets all limits in the inspection procedure.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
The customer reported to olympus, during a therapeutic laparoscopic ligature of communicating hydrocele, the subject device malfunctioned.The pressure on the insufflator was set to 8 but the measured pressure was at 24 and the procedure was aborted.Early in the procedure, the anesthesia nurse reported increased efforts were needed to ventilated the patient adequately.The abdominal pressure was lowered from 12-10mmhg.The patient quickly desaturated to 60%.The anesthesia monitoring equipment was alarming 'high.' at that time is when it was identified the insufflator had blown the abdominal pressure to 24mmhg despite the set pressure limit of 10mmhg.The gas insufflator also alarmed but it was difficult to hear given the high alarms from the anesthesia equipment.The gas hose was immediately disconnected from the patient and the patient's status normalized quickly.A review of the log indicated the duration of severe desaturation was 20 seconds.The subject device was restarted and all the settings were verified to be correct including small cavity selection.The facility proceeded to test the device with low flow and a pressure limit of 8mmhg.The abdominal pressure increased again well above the limit and the device was disconnected when the pressure reached 15mmhg.The procedure was completed using a similar device and there was no further issues.The procedural delay was not reported.It was also reported the patient had an high blood pressure event during the procedure as well.No details were provided.
 
Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is in process.The olympus service center could not confirm any problem with functionality.The device is without any sign of damage.It is very likely that the described problem is caused by a faulty main board where there are pressure sensor circuits and control circuits placed.It is a serious issue and due to this it is recommend to replace the main board to avoid further malfunction.The device meets all limits in the inspection procedure.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.
 
Event Description
The customer reported to olympus, during a therapeutic laparoscopic ligature of communicating hydrocele, the subject device malfunctioned.The pressure on the insufflator was set to 8 but the measured pressure was at 24 and the procedure was aborted.Early in the procedure, the anesthesia nurse reported increased efforts were needed to ventilated the patient adequately.The abdominal pressure was lowered from 12-10mmhg.The patient quickly desaturated to 60%.The anesthesia monitoring equipment was alarming 'high.' at that time is when it was identified the insufflator had blown the abdominal pressure to 24mmhg despite the set pressure limit of 10mmhg.The gas insufflator also alarmed but it was difficult to hear given the high alarms from the anesthesia equipment.The gas hose was immediately disconnected from the patient and the patient's status normalized quickly.A review of the log indicated the duration of severe desaturation was 20 seconds.The subject device was restarted and all the settings were verified to be correct including small cavity selection.The facility proceeded to test the device with low flow and a pressure limit of 8mmhg.The abdominal pressure increased again well above the limit and the device was disconnected when the pressure reached 15mmhg.The procedure was completed using a similar device and there was no further issues.The procedural delay was not reported.It was also reported the patient had an high blood pressure event during the procedure as well.No details were provided.
 
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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, he cause of it could not be identified because no abnormalities were found in the device inspection.Olympus will continue to monitor the field performance of 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 Key13401816
MDR Text Key285731872
Report Number8010047-2022-02186
Device Sequence Number1
Product Code HIF
UDI-Device Identifier04953170324147
UDI-Public04953170324147
Combination Product (y/n)N
Reporter Country CodeNO
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 Physician
Remedial Action Relabeling
Type of Report Initial,Followup,Followup
Report Date 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? Yes
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 Manufacturer01/12/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberZ-0075-2024
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age3 YR
Patient SexMale
-
-