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

• Olympus advise the issue is now resolved and the UHI-4 High Flow Insufflation Unit is now available to order.

• Olympus has released a further update to inform customers about a further software update to correct the causes of over pressurization associated with the UHI-4.
• The new software version corrects a pressure sensor failure detection algorithm. It will detect any pressure sensor failure, intermittent or continuous, during UHI-4 insufflation and will turn off the front panel display and stop gas insufflation as intended.
• The over pressure issue above, which will be addressed by the software update, is not the same as the CR board part failure communicated in March 2024, which requires a CR board replacement. The software update is intended to turn off the system as a normal safety mechanism when a sensor failure is detected. The CR board replacement action is an action to replace sensors on UHI-4 units that are prone to failure.
• The UHI-4 should be considered to remain quarantined at your site until the following corrections are completed.
• Units manufactured before October 2019 require both a CR Board replacement and a software update.
• Units manufactured after October 2019 require a software update only.
• Once the required correction(s) has been performed, you no longer need to quarantine the UHI-4.

Next Steps:

• Read and follow the instructions in this latest Field Safety Notice update.
• Complete the reply form and return to Olympus: RA@Olympus.co.uk to confirm you have received and understood this update to the Field Safety Notice. Reply by 13 September 2024.
• From September onwards an Olympus representative will contact you to arrange a mutually convenient time to have your UHI-4 software and/or CR Board updated on-site or returned to the Olympus repair centre where applicable. Alternatively, you may contact your local Olympus Repair Centre by telephone on 01702 616333.

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.