Field Safety Notice Olympus UHI-4 High Flow Insufflation Unit (ICN 2375)

Important Customer Notice Update

Ref: 2023/2375 ICN Number: 2375

Update:

Olympus has released an update to the Field Safety Notice relating to UHI-4 High Flow Insufflation Unit products.
Olympus has become aware of an increased trend from both repairs and customer complaints of the ‘UHI-4 stopping CO2 gas supply with the front panel LED turning off’. Based on the analysis of customer complaints, the issue was determined to be associated with a control board, or CR board, pressure sensor circuit failure.
To maximize patient safety and mitigate any potential risk to patient health, Olympus will replace the CR board of UHI-4 devices which were manufactured more than five years ago.

Next Steps:

Customers should continue to quarantine the product unless their facility does not have or is unable to obtain an alternative device and chooses to use the UHI-4 with extreme caution, after weighing the potential benefits of the procedure verses the potential risk to health over insufflation described below until:
- For units five years and older – The unit will receive both the software update and a CR board replacement
- For units under five years – The unit will receive the software update only.
Olympus will contact customers based on device age and parts availability to schedule a repair of the CR board. Olympus will be prioritizing customers who have continued to use the UHI-4.
Olympus will contact customers in late summer of 2024 regarding the software update to address the over insufflation.
As always, Olympus requests that customers report complaints, including any injuries during the procedure with UHI-4 to concerns@olympus.com
Please also submit a product complaint form through the NHS Supply Chain link provided –https://www.supplychain.nhs.uk/contact/submit-product-complaint

Alert:

Olympus has released a Field Safety Notice relating to UHI-4 High Flow Insufflation Unit products.
There are three product codes affected.
Olympus has become aware of patients experiencing complications from over-insufflation where UHI-4s were used. Clinical complications cited from Olympus include “short cardiac arrest gas embolism and one death during surgical procedures where the UHI-4 has been used.
These complications may have been due to over-insufflation of the abdominal cavity resulting from the use of the UHI-4 during the procedures. This includes events where the device was reported to not alarm or otherwise notify the user and events where the device did not relieve the over-insufflation to the set pressure.

Products Affected:

The affected products are not available via the NHS Supply Chain catalogue.
These capital products are purchased via OJEU (Official Journal of the European Union) compliant orders using our Unique Reference Number (URN) requested from the buying team.

Next Steps

See our Downloads ▼ section to access the full instructions in the Field Safety Notice and share them with all users of the affected products.
Follow local organisational risk assessment.
You should take the following actions:
1. Discontinue use of the UHI-4 until the root cause investigation is completed
2. Devices should be quarantined and marked appropriately by your site to prevent usage
3. If your facility does not have alternatives or is unable to obtain alternatives, you may choose to use the UHI-4 while exercising extreme caution, after weighing the potential benefits of the procedure versus the potential risk to the health of over-insufflation.
4. If your organisation determines option 3, please ensure staff are made aware of Pages 2 and 3 of the Field Safety Notice CONSIDERATIONS FOR PROVISIONAL USAGE and is applied in addition to patient procedure risk assessment.
Olympus requests that you report complaints, including any injuries associated with over-insufflation during the procedure with UHI-4, to Olympus.
Please report complaints to concerns@olympus.co.uk
If you require additional information, please do not hesitate to contact the supplier at ra@olympus.co.uk
If you have any further questions, please contact your local NHS Supply Chain Hospital Care team.

2375 Olympus Field Safety Notice Update 22 May 2024
A PDF showing the Field Safety Notice update for ICN 2375.
2375 Olympus Field Safety Notice UHI 4 Overpressure 15 December 2023
A PDF showing the Field Safety Notice for ICN 2375.
2375 Olympus Instructions Addendum UHI 4 High Flow 15 December 2023
A PDF showing the instructions for use for ICN 2379.